Clinical trial NCT00423800: Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)
Official title: Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) Therapy (1.5 mcg/kg/Week + 800-1200 mg/Day) in Naïve Genotype 1 Hepatitis C Patients With High Baseline Viral Load Who Are HCV-RNA Negative at Week 4 and Week 12
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-01-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase IIIB randomized, controlled, multi-centre, open-label study of 24 versus 48 weeks therapy with Pegetron® (peginterferon alfa-2b + ribavirin) at standard doses in naïve Hepatitis C Virus (HCV) genotype 1 high viral load (HVL) participants who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at Week 4. HVL will be defined as HCV-RNA of \>600,000 IU/mL prior to the initiation of therapy. Participants with genotype 1 baseline HVL prescribed Pegetron® (peginterferon and ribavirin) in the usual manner in accordance with the marketing authorization and who are viral negative at Week 4 will be randomized at Week 8 to receive a total of 24 or 48 weeks of therapy. Participants will be required to have their baseline and Week-12 viral load analyzed by the same local laboratory using the standard of care test used by the site. Qualitative testing at Week 4, 8, 16-20, 24, and 48 may be conducted either by local laboratory or a central laboratory identified by the sponsor using an assay specified by the sponsor. No additional interventions outside of the clinic's standard of care and the conditions of the Canadian product monograph for Pegetron® will be applied to participants.


Eligibility criteria: Inclusion Criteria:

* Must demonstrate willingness to participate in the study.
* Diagnosed with chronic HCV.
* Between 18 and 65 years of age of either gender and of any race.
* a. HCV positive, \>600,000 IU/mL at baseline AND b. Genotype 1.
* Suitable for treatment with Pegetron® per the Canadian product monograph.
* Investigator has already decided to treat with PEGETRON REDIPEN®

1.5mcg/kg/week of peginterferon alpha-2b plus 800-1200 mg /day of ribavirin.

* HCV-RNA negative at treatment week 4.
* Meet certain minimum laboratory values at the week 4 screening visit.
* Women of childbearing potential and male partners must agree to use a medically accepted method of contraception prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication. Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, oral or injectable hormonal contraceptive, and surgical sterilization (e.g. hysterectomy or tubal ligation).

Exclusion Criteria:

* Had previous interferon-based therapy for Chronic Hepatitis C.
* Active Hepatitis B virus (HBV) infection.
* Human Immunodeficiency Virus (HIV) antibody positive.
* Cirrhotic (Stage 4 on Metavir system).
* Uncontrolled history or current severe depression or psychoses.
* Uncontrolled epilepsy.
* Use of illicit drugs.
* History of non-compliance to medical regimens.
* Liver disease other than from chronic hepatitis C.
* Participating in any other clinical study.
* Used any investigational drugs within 30 days of screening.
* Participants weighing \< 40 kg or \> 125 kg.
* Pregnant women or women who plan to become pregnant or sexual partners of women who want to become pregnant.

Primary outcomes:
measure: Number of Participants With a Sustained Virologic Response
timeFrame: 24 weeks following completion of 24 or 48 weeks of therapy
Secondary outcomes:
measure: Number of Participants With a Virological Relapse
timeFrame: 24 weeks following completion of 24 or 48 weeks of therapy
Other outcomes:
Locations:
Study officials:
References: