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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01054573




Trial ID
NCT01054573
Ethics application status
Date submitted
21/01/2010
Date registered
21/01/2010
Date last updated
6/05/2013

Titles & IDs
Public title
VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo
Scientific title
An Open-label, Single-arm, Roll-over Trial of Telaprevir in Combination With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) for Subjects From the Control Group of the VX- 950-TiDP24-C216 Trial Who Failed Therapy for Virologic Reasons
Secondary ID [1] 0 0
VX-TiDP24-C219
Secondary ID [2] 0 0
CR016678
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
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 - Telaprevir
Treatment: Drugs - pegylated interferon (Peg-IFN) alfa-2a
Treatment: Drugs - ribavirin (RBV)

Experimental: Telaprevir + Standard Treatment - Telaprevir 750 mg orally (by mouth) every 8h for 12 weeks plus standard treatment. Standard treatment is 180 mcg subcutaneous (under the skin) injection pegylated interferon (Peg-IFN) alfa-2a and 1000-1200 mg twice daily ribavirin (RBV) for 48 weeks.


Treatment: Drugs: Telaprevir
750 mg orally every 8 hours (q8h) for 12 weeks

Treatment: Drugs: pegylated interferon (Peg-IFN) alfa-2a
180 microgram (mcg) by subcutaneous injection once weekly for 48 weeks.

Treatment: Drugs: ribavirin (RBV)
1,000 or 1,200 mg/day (weight based) orally twice daily for 48 weeks.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual) - The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of < 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure.
Timepoint [1] 0 0
End of trial (24 weeks after last dose, administerd at 48 weeks)
Secondary outcome [1] 0 0
The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points - The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels of less than 25 IU/ml, target not detected at different time points during the study. Data was imputed for participants with missing values using the last observation carried forward (LOCF) method for missing values.
Timepoint [1] 0 0
Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation)
Secondary outcome [2] 0 0
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8 - The table below shows the percentage of participants at Week 4 or 8 who met a stopping rule defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value >100 IU/mL.
Timepoint [2] 0 0
Week 4, Week 8
Secondary outcome [3] 0 0
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 - The table below shows the percentage of participants at Week 12, 24, and 36 who met a stopping rule. The stopping rule at Week 12 was having hepatitis C virus (HCV) ribonucleic acid (RNA) value of >100 IU/mL and the stopping rule at Weeks 24 or 36 was having a HCV RNA value of >=25 IU/mL.
Timepoint [3] 0 0
Week 12 or Weeks 24 or 36
Secondary outcome [4] 0 0
Percentage of Participants Achieving Rapid Virologic Response (RVR) - The table below shows the percentage of participants who had a rapid virologic response (RVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at Week 4 of treatment).
Timepoint [4] 0 0
Week 4
Secondary outcome [5] 0 0
Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR) - The table below shows the percentage of participants who had a Extended Rapid Virologic Response (eRVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at at Weeks 4 and 12 of treatment).
Timepoint [5] 0 0
Weeks 4 and 12
Secondary outcome [6] 0 0
Percentage of Participants With Viral Breakthrough - The table below shows the percentage of participants with viral breakthrough defined as a confirmed increase >1 log10 in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached during the considered treatment phase up to the considered time point, if the lowest level reached is > 25 IU/mL, or a confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA had previously become <25 IU/mL (detected or target not detected) during the considered treatment phase.
Timepoint [6] 0 0
Week 48 (Period After Telaprevir Intake) and Week 12 (Telaprevir Treatment Phase)
Secondary outcome [7] 0 0
Percentage of Participants Who Relapsed During Follow-Up - The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 24-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).
Timepoint [7] 0 0
During Follow-Up (24 weeks after the last dose of study drug, administerd at 48 weeks)
Secondary outcome [8] 0 0
Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time - The table below shows plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) values measured over time.
Timepoint [8] 0 0
Baseline, Weeks 4, 8, 12, 24, 36, 48
Secondary outcome [9] 0 0
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level - The table below shows change from baseline in log 10 plasma HCV RNA values measured over time.
Timepoint [9] 0 0
Baseline, Weeks 4, 8, 12, 24, 36, and 48

Eligibility
Key inclusion criteria
- Patient from the control group of the C216 study who failed therapy for virologic
reasons

- Patient must have completed all assessments in the C216 trial

- Patient must be willing to use 2 effective methods of birth control for up to 7 months
after last dose of study medication
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient received any direct acting anti-viral HCV therapy after discontinuation of the
C216 trial

- Patient has history of decompensated liver disease

- Patient has history of acute or chronic pancreatitis

- Patient has condition that requires use of systemic corticosteroids

- Patient who prematurely stopped medication for non-compliance or for whom it would be
unsafe to repeat treatment

- Patient has history of decompensated liver disease or history of cirrhosis with
hepatocellular carcinoma

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Single group
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Clayton
Recruitment hospital [3] 0 0
- Darlinghurst
Recruitment hospital [4] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Darlinghurst
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Belgium
State/province [11] 0 0
Brussels
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Brazil
State/province [14] 0 0
Distrito Barao Geraldo-Campina
Country [15] 0 0
Brazil
State/province [15] 0 0
Salvador
Country [16] 0 0
Brazil
State/province [16] 0 0
Sao Paulo
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
France
State/province [18] 0 0
Clichy
Country [19] 0 0
France
State/province [19] 0 0
Créteil
Country [20] 0 0
France
State/province [20] 0 0
Lille Cedex
Country [21] 0 0
France
State/province [21] 0 0
Pessac
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin
Country [23] 0 0
Germany
State/province [23] 0 0
Frankfurt
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Germany
State/province [25] 0 0
Hannover
Country [26] 0 0
Germany
State/province [26] 0 0
Köln
Country [27] 0 0
Germany
State/province [27] 0 0
München
Country [28] 0 0
Israel
State/province [28] 0 0
Petah Tiqva
Country [29] 0 0
Israel
State/province [29] 0 0
Zefat
Country [30] 0 0
Netherlands
State/province [30] 0 0
Amsterdam
Country [31] 0 0
Netherlands
State/province [31] 0 0
Nijmegen
Country [32] 0 0
Poland
State/province [32] 0 0
Bialystok
Country [33] 0 0
Poland
State/province [33] 0 0
Czeladz
Country [34] 0 0
Poland
State/province [34] 0 0
Warszawa
Country [35] 0 0
Puerto Rico
State/province [35] 0 0
San Juan
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Valencia
Country [38] 0 0
Sweden
State/province [38] 0 0
Stockholm
Country [39] 0 0
Switzerland
State/province [39] 0 0
Zurich N/A
Country [40] 0 0
United Kingdom
State/province [40] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Infectious Diseases BVBA
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Vertex Pharmaceuticals Incorporated
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to provide access to telaprevir for patients from the control
group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and
tolerability of telaprevir in combination with standard treatment will be evaluated.
Trial website
https://clinicaltrials.gov/show/NCT01054573
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Infectious Diseases BVBA Clinical Trial
Address 0 0
Janssen Infectious Diseases BVBA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries