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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01519960

Registration number

NCT01519960

Ethics application status

Date submitted

6/12/2011

Date registered

27/01/2012

Date last updated

18/11/2022

Titles & IDs

Public title

A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

Scientific title

A Phase IIIb Parallel Group, Open Label Study of Pegylated Interferon Alfa-2a Monotherapy (PEG-IFN, Ro 25-8310) Compared to Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

Secondary ID [1]

2011-002732-70

Secondary ID [2]

YV25718

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hepatitis B, Chronic

Condition category

Condition code

Infection

Other infectious diseases

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - peginterferon alfa-2a [Pegasys]
Treatment: Drugs - peginterferon alfa-2a [Pegasys]

Experimental: A Pegasys -

No Intervention: B Untreated Control -

Experimental: C Fibrosis non-randomized -

Experimental: Switch -

Treatment: Drugs: peginterferon alfa-2a [Pegasys]
Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48

Treatment: Drugs: peginterferon alfa-2a [Pegasys]
Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, after Week 48 for Group B patients who have not experienced HBeAg seroconversion

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B

Timepoint [1]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [1]

Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B

Timepoint [1]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [2]

Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B

Timepoint [2]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [3]

Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B

Timepoint [3]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [4]

Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B

Timepoint [4]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [5]

Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B

Timepoint [5]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [6]

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B

Timepoint [6]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [7]

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B

Timepoint [7]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [8]

Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B

Timepoint [8]

Week 48

Secondary outcome [9]

Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B

Timepoint [9]

Week 48

Secondary outcome [10]

Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B

Timepoint [10]

Week 48

Secondary outcome [11]

Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B

Timepoint [11]

Week 48

Secondary outcome [12]

Percentage of Participants With Normal ALT at EOT/POP in Groups A and B

Timepoint [12]

Week 48

Secondary outcome [13]

Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B

Timepoint [13]

Week 48

Secondary outcome [14]

Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B

Timepoint [14]

Week 48

Secondary outcome [15]

Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B

Timepoint [15]

Week 48

Secondary outcome [16]

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B

Timepoint [16]

Week 48

Secondary outcome [17]

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B

Timepoint [17]

Week 48

Secondary outcome [18]

Quantitative Serum ALT Level in Groups A and B

Timepoint [18]

Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Secondary outcome [19]

Quantitative HBV DNA Level in Groups A and B

Timepoint [19]

Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Secondary outcome [20]

Change From Baseline in Quantitative HBV DNA Level in Groups A and B

Timepoint [20]

Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Secondary outcome [21]

Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C

Timepoint [21]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [22]

Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C

Timepoint [22]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [23]

Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C

Timepoint [23]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [24]

Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C

Timepoint [24]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [25]

Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C

Timepoint [25]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [26]

Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C

Timepoint [26]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [27]

Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C

Timepoint [27]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [28]

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C

Timepoint [28]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [29]

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C

Timepoint [29]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [30]

Percentage of Participants With HBeAg Seroconversion at EOT in Group C

Timepoint [30]

Week 48

Secondary outcome [31]

Percentage of Participants With Loss of HBeAg at EOT in Group C

Timepoint [31]

Week 48

Secondary outcome [32]

Percentage of Participants With HBsAg Seroconversion at EOT in Group C

Timepoint [32]

Week 48

Secondary outcome [33]

Percentage of Participants With Loss of HBsAg at EOT in Group C

Timepoint [33]

Week 48

Secondary outcome [34]

Percentage of Participants With Normal ALT at EOT in Group C

Timepoint [34]

Week 48

Secondary outcome [35]

Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C

Timepoint [35]

Week 48

Secondary outcome [36]

Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C

Timepoint [36]

Week 48

Secondary outcome [37]

Percentage of Participants With HBV DNA Undetectable at EOT in Group C

Timepoint [37]

Week 48

Secondary outcome [38]

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C

Timepoint [38]

Week 48

Secondary outcome [39]

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C

Timepoint [39]

Week 48

Secondary outcome [40]

Quantitative Serum ALT Level in Group C

Timepoint [40]

Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Secondary outcome [41]

Quantitative HBV DNA Level in Group C

Timepoint [41]

Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Secondary outcome [42]

Change From Baseline in Quantitative HBV DNA Level in Group C

Timepoint [42]

Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Secondary outcome [43]

Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category

Timepoint [43]

Pre-dose (0 hours) at Baseline and Weeks 4, 8, 12, 24; post-dose (24-48, 72-96, 168 hours) during Weeks 1, 24 (up to 24 weeks overall)

Secondary outcome [44]

Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B

Timepoint [44]

Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)

Secondary outcome [45]

Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B

Timepoint [45]

Weeks 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Secondary outcome [46]

Quantitative HBeAg Level in Groups A and B

Timepoint [46]

Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Secondary outcome [47]

Quantitative HBsAg Level in Groups A and B

Timepoint [47]

Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Secondary outcome [48]

Quantitative HBeAg Level in Group C

Timepoint [48]

Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Secondary outcome [49]

Quantitative HBsAg Level in Group C

Timepoint [49]

Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Secondary outcome [50]

Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C

Timepoint [50]

Week 48; FU Week 24 (up to 72 weeks overall)

Secondary outcome [51]

Percentage of Participants With >15% Drop in Height Percentile for Age in Group C

Timepoint [51]

Weeks 30, 36; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Secondary outcome [52]

Change From Baseline in Height for Age Z-Score in Groups A and B

Timepoint [52]

Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)

Secondary outcome [53]

Change From Baseline in Weight for Age Z-Score in Groups A and B

Timepoint [53]

Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Secondary outcome [54]

Change From Baseline in Height for Age Z-Score in Group C

Timepoint [54]

Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)

Secondary outcome [55]

Change From Baseline in Weight for Age Z-Score in Group C

Timepoint [55]

Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Secondary outcome [56]

Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C

Timepoint [56]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [57]

Change From Baseline in Quantitative Serum ALT Level in Groups A and B

Timepoint [57]

Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Secondary outcome [58]

Change From Baseline in Quantitative HBeAg Level in Groups A and B

Timepoint [58]

Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Secondary outcome [59]

Change From Baseline in Quantitative HBsAg Level in Groups A and B

Timepoint [59]

Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Secondary outcome [60]

Change From Baseline in Quantitative Serum ALT Level in Group C

Timepoint [60]

Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Secondary outcome [61]

Change From Baseline in Quantitative HBeAg Level in Group C

Timepoint [61]

Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Secondary outcome [62]

Change From Baseline in Quantitative HBsAg Level in Group C

Timepoint [62]

Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Secondary outcome [63]

Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B

Timepoint [63]

Baseline, FU Years: 1, 2, 3, 4, 5

Secondary outcome [64]

Percentage of Participants With Loss of HBeAg at 24 Weeks After the End of Switch Treatment Period: Switch Group

Timepoint [64]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [65]

Percentage of Participants With HBsAg Seroconversion at 24 Weeks After the End of Switch Treatment Period: Switch Group

Timepoint [65]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [66]

Percentage of Participants With Loss of HBsAg at 24 Weeks After the End of Switch Treatment Period: Switch Group

Timepoint [66]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [67]

Percentage of Participants With Normal ALT at 24 Weeks After the End of Switch Treatment Period: Switch Group

Timepoint [67]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [68]

Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After the End of Switch Treatment Period: Switch Group

Timepoint [68]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [69]

Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group

Timepoint [69]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [70]

Percentage of Participants With HBV DNA Undetectable at 24 Weeks After the End of Switch Treatment Period: Switch Group

Timepoint [70]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [71]

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group

Timepoint [71]

FU Week 24 (up to 72 weeks overall)

Secondary outcome [72]

Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group

Timepoint [72]

FU Week 24 (up to 72 weeks overall)

Eligibility

Key inclusion criteria

- Male or female patients, 3 years to <18 years of age at baseline

- Positive HBsAg for more than 6 months

- Positive HBeAg and detectable HBV DNA at screening

- A liver biopsy obtained within the past 2 years prior to baseline (and more than 6
months after the end of previous therapy for hepatitis B) to confirm the presence of
advanced fibrosis or exclude cirrhosis

- Compensated liver disease (Child-Pugh Class A)

- Elevated serum alanine transferase (ALT)

- Normal thyroid gland function at screening

Minimum age

3 Years

Maximum age

17 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Subjects with cirrhosis

- Subjects must not have received investigational drugs or licensed treatments with
anti-HBV activity within 6 months of baseline. Subjects who are expected to need
systemic antiviral therapy other than that provided by the study at any time during
their participation in the study are also excluded

- Known hypersensitivity to peginterferon

- Positive test results at screening for hepatitis A, hepatitis C, hepatitis D or HIV
infection

- History or evidence of medical condition associated with chronic liver disease other
than chronic hepatitis B

- History or evidence of bleeding from esophageal varices

- Decompensated liver disease (e.g. ascites, Child-Pugh Class B or C)

- History of immunologically mediated disease

- Pregnant or lactating females

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

11/07/2012

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

18/10/2021

Sample size

Target

Accrual to date

Final

165

Recruitment in Australia

Recruitment state(s)

SA,VIC

Recruitment hospital [1]

Womens and Childrens Hospital; Department of Gastroenterology - North Adelaide

Recruitment hospital [2]

Royal Children's Hospital; Department of Gastroenterology - Melbourne

Recruitment postcode(s) [1]

5006 - North Adelaide

Recruitment postcode(s) [2]

3053 - Melbourne

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

California

Country [2]

United States of America

State/province [2]

Maryland

Country [3]

United States of America

State/province [3]

Massachusetts

Country [4]

United States of America

State/province [4]

Missouri

Country [5]

United States of America

State/province [5]

Texas

Country [6]

United States of America

State/province [6]

Washington

Country [7]

Belgium

State/province [7]

Bruxelles

Country [8]

Belgium

State/province [8]

Gent

Country [9]

Bulgaria

State/province [9]

Sofia

Country [10]

Bulgaria

State/province [10]

Varna

Country [11]

China

State/province [11]

Beijing City

Country [12]

China

State/province [12]

Beijing

Country [13]

China

State/province [13]

Changchun

Country [14]

China

State/province [14]

Chongqing

Country [15]

China

State/province [15]

Guangzhou

Country [16]

China

State/province [16]

Kunming

Country [17]

China

State/province [17]

Urumqi (????)

Country [18]

China

State/province [18]

Wuhan

Country [19]

China

State/province [19]

Xi'an

Country [20]

Germany

State/province [20]

Wuppertal

Country [21]

Israel

State/province [21]

Haifa

Country [22]

Israel

State/province [22]

Jerusalem

Country [23]

Israel

State/province [23]

Nahariya

Country [24]

Italy

State/province [24]

Emilia-Romagna

Country [25]

Poland

State/province [25]

Bydgoszcz

Country [26]

Poland

State/province [26]

Krakow

Country [27]

Poland

State/province [27]

Lodz

Country [28]

Russian Federation

State/province [28]

Moscow

Country [29]

Russian Federation

State/province [29]

Saint Petersburg

Country [30]

Russian Federation

State/province [30]

Samara

Country [31]

Ukraine

State/province [31]

Kyiv

Country [32]

United Kingdom

State/province [32]

Birmingham

Country [33]

United Kingdom

State/province [33]

London

Funding & Sponsors

Primary sponsor type

Commercial sector/Industry

Name

Hoffmann-La Roche

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

This parallel group, open label study will evaluate the safety and efficacy of Pegasys
(peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at
baseline) with HBeAg positive chronic hepatitis B. Children without advanced fibrosis and
without cirrhosis will be randomized 2:1 to treatment Group A, receiving Pegasys 45-180 mcg
subcutaneously weekly for 48 weeks, or to the untreated control Group B. Children with
advanced fibrosis will be assigned to treatment group C and receive 48 weeks of treatment
with Pegasys. Children in the untreated control Group B who have not experienced
seroconversion 48 weeks after randomization may enter the Switch Arm to receive 48 weeks of
Pegasys treatment. This offer will be available for 1 year following 48 weeks from
randomization. Anticipated time on study treatment is 48 weeks. All subjects will be followed
up for 5 years after the end of treatment (A,C,Switch)/principal observation (B) period.

Trial website

https://clinicaltrials.gov/ct2/show/NCT01519960

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Clinical Trials

Address

Hoffmann-La Roche

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01519960

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01519960