Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01336010




Trial ID
NCT01336010
Ethics application status
Date submitted
13/04/2011
Date registered
13/04/2011
Date last updated
31/08/2015

Titles & IDs
Public title
Treatment of Recently Acquired Hepatitis C Virus Infection
Scientific title
Treatment of Recently Acquired Hepatitis C Virus Infection
Secondary ID [1] 0 0
5R01DA015999-07
Universal Trial Number (UTN)
Trial acronym
ATAHC-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Hepatitis C 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 - Peginterferon alfa-2a
Treatment: Drugs - Ribavirin

Experimental: Group A - 8 weeks therapy - 8 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 2 weeks of therapy.

Experimental: Group B - 16 weeks therapy - 16 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 4 weeks of therapy.

Experimental: Group C - 24 weeks therapy - 24 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 6 weeks of therapy.

Experimental: Group D - 32 weeks (gt1) or 24 weeks (gt 2/3) - 32 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 8 weeks of therapy (genotype 1) or 24 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 8 weeks of therapy.

Experimental: Group E - 48 weeks (gt 1) or 24 weeks (gt 2/3) - 48 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 12 weeks of therapy (genotype 1) or 24 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 12 weeks of therapy (genotype 2/3).

No Intervention: Untreated Group - Observation only. No treatment for hepatitis C administered. Subjects who have undetectable HCV RNA at baseline, do not wish to commence treatment or are ineligible for treatment.


Treatment: Drugs: Peginterferon alfa-2a
PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly

Treatment: Drugs: Ribavirin
Genotype 1: 1000mg or 1200mg p.o. daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing = 75kg) Genotypes 2/3: 800mg daily p.o. daily in split doses for genotype 2 and 3 patients

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

Outcomes
Primary outcome [1] 0 0
Evaluate the safety and efficacy of response-guided pegylated interferon and ribavirin for the treatment of recent HCV infection. Response-guided means the duration of treatment will be determined by the subject's early response to treatment. - Treatment duration will be determined by time to undetectable HCV RNA. Undetectable at week 2=8 weeks of therapy; Undetectable at week 4=16 weeks of therapy; Undetectable at week 6=24 weeks of therapy; Undetectable at week 8=32 weeks of therapy (24 weeks for genotypes 2/3); Undetectable at week 12=48 weeks of therapy (24 weeks for genotypes 2/3);
Timepoint [1] 0 0
8-48 weeks

Eligibility
Key inclusion criteria
- Male and female patients = 16 years of age

- Recent hepatitis C infection with an estimated duration of Infection = 18 months
defined as

A)

- i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and

- ii) Documented anti-HCV antibody negative or HCV RNA negative within the 24 months
prior to anti-HCV antibody positive result

OR

B)

- i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and

- ii) acute clinical hepatitis (jaundice or ALT> 10 X ULN) within the 12 months prior to
first positive HCV antibody or HCV RNA with no other cause of acute hepatitis
identifiable and

- Adequate English to provide written, informed consent and to provide reliable
responses to the study interview

- Provision of written, informed consent.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All patients:

• Individuals considered by the study investigators to be unlikely to participate in
intensive follow-up and/or unwilling to provide extra blood samples

Treatment group only:

- Age between 16 and 18 years

- Women with ongoing pregnancy or breast feeding

- Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment
(including supraphysiologic doses of steroids and radiation) *6 months prior to the
first dose of study drug

- Any investigational drug <6 weeks prior to the first dose of study drug

- Positive test at screening for anti-HAV IgM Ab, anti-HBc IgM Ab

- History or other evidence of a medical condition associated with chronic liver disease
other than HCV (e.g. hemochromatosis, autoimmune hepatitis, metabolic liver disease,
alcoholic liver disease, toxin exposures)

- History or other evidence of bleeding from esophageal varices or other conditions
consistent with decompensated liver disease

- Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening

- Serum creatinine level >1.5 times the upper limit of normal at screening

- Hgb< 12g/dL in women or < 13g/dL in men at screening (for patients who receive
combination therapy with PEG-IFN and ribavirin only)

- Male partners of women who are pregnant (for patients who receive combination therapy
with PEG-IFN and ribavirin only)

- History of a severe seizure disorder or current anticonvulsant use

- History of immunologically mediated disease, chronic pulmonary disease associated with
functional limitation, severe cardiac disease, major organ transplantation or other
evidence of severe illness, malignancy, or any other conditions which would make the
patient, in the opinion of the investigator, unsuitable for the study

- History of thyroid disease poorly controlled on prescribed medications, elevated
thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to
thyroid peroxidase and any clinical manifestations of thyroid disease

- Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
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)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Kirketon Road Centre - Darlinghurst
Recruitment hospital [3] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [4] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment hospital [5] 0 0
Nepean Hospital - Penrith
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3065 - Melbourne
Recruitment postcode(s) [4] 0 0
2751 - Penrith
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3065 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To determine whether response guided treatment with pegylated interferon +/- ribavirin is
effective for the treatment of recently acquired hepatitis C infection. Response guided
treatment is when the length of treatment is determined by how quickly you respond to the
treatment.
Trial website
https://clinicaltrials.gov/show/NCT01336010
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregory J Dore, MBBS, PhD
Address 0 0
University of New South Wales
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