Peg-Intron/Ribavirin in G 1 HCV for Non-Extended Versus 24 Week Extended Treatment After 24 Weeks (Study P04144)(COMPLETED)

NCT ID: NCT00202839

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2008-07-31

Brief Summary

This is an open-label, randomized, comparative, multicenter, 48-week study designed to evaluate the efficacy and safety of combination treatment with pegylated interferon and ribavirin in adult subjects with a diagnosis of compensated chronic hepatitis C (hepatitis C virus (HCV)-ribonucleic acid (RNA) positive) (Genotype 1). All subjects will complete 24 weeks of treatment, termed the Pilot Treatment Program, after which all eligible subjects will be randomly assigned to one of two study groups. One group will be followed for an additional 48 weeks without study medication, while the other will be continuously treated for an additional 24 weeks and then followed for another 24 weeks without study medication. Sustained virologic response, defined as undetectable HCV-RNA in serum at the end of the follow-up period, will be measured along with other outcomes.

Detailed Description

This is an open-label, randomized, comparative, multicenter study for evaluation of PegIntron/Ribavirin therapy in the efficacy and safety in adult subjects with a diagnosis of compensated chronic hepatitis C (HCV-RNA+) (Genotype 1). This is a 48-week study, for which all subjects should participate in the Pilot Treatment Program and complete 24 weeks treatment. To avoid a treatment gap, subjects who will be screened and eligible subjects will sign informed consent prior to the end of the Pilot Treatment Program. After completion of the Pilot Treatment Program, all eligible subjects will be randomly assigned to either study group. Subjects in the 24-Week Treatment arm will be followed-up without study medication for 48 weeks; subjects in the 48-Week Treatment arm will be continuously treated for another 24 weeks and all subjects in the 48-Week Treatment arm will be followed for another 24 weeks after completion of the treatment period. Subjects in both arms will be evaluated at screening, randomization, 4, 8, 12, 16, 20, 24, 28, 36 and 48 weeks after randomization.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

24-Week Treatment

Genotype 1 hepatitis C virus \[HCV\] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)

Group Type: EXPERIMENTAL

PegIntron (peginterferon alfa-2b; SCH 54031)

Intervention Type: BIOLOGICAL

Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program

Ribavirin

Intervention Type: DRUG

200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program

48-Week Treatment

Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)

Group Type: ACTIVE_COMPARATOR

PegIntron (peginterferon alfa-2b; SCH 54031)

Intervention Type: BIOLOGICAL

Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program followed by 1.2 to 1.5 microgram/kg weekly for 24 weeks during the extended treatment program

Ribavirin

Intervention Type: DRUG

200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program and for 24 weeks during the extended treatment program

Interventions

PegIntron (peginterferon alfa-2b; SCH 54031)

Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program

Intervention Type: BIOLOGICAL

PegIntron (peginterferon alfa-2b; SCH 54031)

Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program followed by 1.2 to 1.5 microgram/kg weekly for 24 weeks during the extended treatment program

Intervention Type: BIOLOGICAL

Ribavirin

200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program

Intervention Type: DRUG

Ribavirin

200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program and for 24 weeks during the extended treatment program

Intervention Type: DRUG

Other Intervention Names

peginterferon alfa-2b; SCH 54031; peginterferon alfa-2b; SCH 54031; SCH 18908; SCH 18908

Eligibility Criteria

Inclusion Criteria

• Subject must be willing to give written informed consent and be able to adhere to dose and visit schedules.
• Males and non-pregnant females and aged >= 18 years, subjects who are over 65 years of age must be in generally good health and must be discussed with and approved by the principal investigator prior to entry.
• The laboratory evaluation within 6 months prior to entering the Pilot Treatment Program must meet the following criteria:
• Hemoglobin values of >= 12 g/dL for females and >= 13 g/dL for males
• Neutrophil count >= 1.5 X10^9/L
• Platelets count >= 100 x 10^9/L
• Total bilirubin < 1.5 mg/dL
• Serum creatinine within normal limits
• Positive serum HCV-RNA (>= 50 IU (100 copy numbers)/mL)
• Anti-HCV positive
• Available HCV genotype 1
• Liver biopsy performed within 12 months prior to entry to this protocol with a pathology report confirming that the histological diagnosis is consistent with chronic hepatitis (METAVIR system >=F1).
• Compensated liver disease with the following hematological, biochemical, and serologic criteria at the screening visit:
• Hemoglobin values of >= 9 g/dL
• Neutrophil count >= 0.75 x 10^9/L
• Platelets count >= 50 x 10^9/L
• Prothrombin time (PT) prolong <= 3 sec, International Normalized Ratio (INR) <= 1.2
• Total bilirubin <= 3 mg/dL

Exclusion Criteria

• Anti-Human Immunodeficiency Virus (HIV) negative.
• Alpha-fetoprotein (AFP) value within normal limits obtained within 12 months prior to entry. Results above the upper limit of normal but <= 50 ng/mL require both of the following:
• AFP value <= 50 ng/mL obtained within 9 months prior to entry in the study or during the Screening period, and Ultrasound obtained within 9 months prior to entry or in the screening period in the study for evidence of not having hepatocellular carcinoma.
• A urine pregnancy test obtained prior to the initiation of pilot treatment must be negative. Female subjects must not be breast feeding.
• Reconfirmation that sexually-active subjects are practicing acceptable methods of contraception during screening period.
• Complete 24 weeks treatment of the Pilot Treatment Program with Peg-Intron + Ribavirin.
• Must be never treated with interferon for HCV infected hepatitis (treatment naïve) before the Pilot Treatment Program.
• The total amount of Peg-Intron and Ribavirin received during the pilot treatment program must achieve more than 80% of the recommended dosage.

• Women who are pregnant or nursing.
• Have decompensated cirrhosis.
• History of severe psychiatric disease, especially depression.
• Concurrent malignancies (including hepatocellular carcinoma).
• Unstable or significant cardiovascular diseases. Subjects with (ECG) showing clinically significant abnormalities.
• Prolonged exposure to known hepatotoxins such as alcohol or drugs.
• History of thyroid disease poorly controlled on prescribed medication.
• Poorly controlled diabetes mellitus.
• Has suspected or confirmed significant hepatic disease from an etiology other than HCV.
• Patients co-infected with hepatitis B and /or human immunodeficiency virus (HIV).
• Severe renal disease or myeloid dysfunction.
• History of organ transplantation other than cornea and hair transplant.
• Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
• Any other condition which in the opinion of the investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol.
• Allergy to interferon.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ding-Shinn Chen, MD

Role: STUDY_CHAIR

Investigational Site

Other Identifiers

P04144

Identifier Type: -

Identifier Source: org_study_id