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

NCT00202839 | Completed Phase 4 Results

• 1 other identifier: P04144
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR)

  Sustained virologic response was defined as hepatitis C virus ribonucleic acid \[HCV-RNA\] levels below assay detection 24 weeks after termination of anti-HCV therapy

  24 weeks of follow-up after either 24 or 48 weeks of anti-HCV therapy

Secondary Outcomes (1)

• The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization.

  48 weeks after randomization (with 24 weeks of treatment immediately before randomization and either 0 or 24 weeks of treatment immediately after randomization)

Study Arms (2)

24-Week Treatment

EXPERIMENTAL

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

Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Ribavirin

48-Week Treatment

ACTIVE COMPARATOR

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)

Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Ribavirin

Interventions

PegIntron (peginterferon alfa-2b; SCH 54031) 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

Also known as: peginterferon alfa-2b; SCH 54031

24-Week Treatment

Ribavirin DRUG

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

Also known as: SCH 18908

24-Week Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Study Officials

• Ding-Shinn Chen, MD

  Investigational Site

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: March 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: April 6, 2017
• Results First Posted: March 24, 2011

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share