Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)

This study has been completed.
Sponsor:
Collaborator:
Biokos Farma srl
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00686517
First received: May 27, 2008
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3) a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the treatment period, participants will enter a 12-month follow-up.


Condition Intervention Phase
Hepatitis C
Biological: Pegylated interferon alfa-2b
Drug: Ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Randomized, Multicentre Trial to Evaluate Efficacy and Safety of a 24-week Course of PEG-Interferon Alpha-2b Versus a 12-week Course of PEG-Interferon Alpha-2b Alone or Plus Ribavirin in Patients With Acute Hepatitis C

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period [ Time Frame: Evaluated at the end of 6 months ] [ Designated as safety issue: No ]
    SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.


Secondary Outcome Measures:
  • Virologic Response at the End of Treatment Follow-up (ETR) [ Time Frame: At the end of treatment (either 12 weeks or 24 weeks depending on randomization). ] [ Designated as safety issue: No ]

    ETR was achieved if serum HCV RNA level at the end of 12 or 24 weeks

    treatment (depending on treatment arm) was <15 IU/mL.


  • Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]). [ Time Frame: At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization). ] [ Designated as safety issue: No ]
    LTR was obtained if serum HCV RNA level at the end of 12-month follow-up was <15 IU/mL.

  • Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization [ Time Frame: Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit. ] [ Designated as safety issue: No ]
    ALT normalization was used as a measure of biochemical response to treatment. ALT levels were assessed at each study visit by the local laboratory, and efficacy measurements at the end of treatment, at 6 and 12 months post treatment follow-up were reported.

  • Number of Participants With Rapid Virologic Response (RVR) [ Time Frame: Evaluated at 2 and 4 weeks of treatment ] [ Designated as safety issue: No ]

    Participants were considered to have RVR if serum HCV RNA level at 2 or 4

    weeks of treatment was below the cut off value of the referring local

    laboratory of each participating site.


  • Number of Peripheral Blood Mononuclear Cells (PBMCs) [ Time Frame: Treatment Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Cellular Differentiation Cluster Antigen 8-Positive (CD8+) PBMCs were measured at randomization, Treatment Weeks 2, 4, 8, and 12.


Enrollment: 130
Study Start Date: December 2003
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEG-IFN 24
pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
Biological: Pegylated interferon alfa-2b
1.5 ug/kg/week SC for 12 or 24 weeks
Other Name: SCH 54031, PegIntron
Experimental: PEG-IFN 12
pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
Biological: Pegylated interferon alfa-2b
1.5 ug/kg/week SC for 12 or 24 weeks
Other Name: SCH 54031, PegIntron
Experimental: PEG-IFN + RVB 12
pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin at the dose of 10.6 mg/kg/day for 12 weeks
Biological: Pegylated interferon alfa-2b
1.5 ug/kg/week SC for 12 or 24 weeks
Other Name: SCH 54031, PegIntron
Drug: Ribavirin
Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks
Other Name: SCH 18908, Rebetol

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with acute hepatitis C virus (HCV).
  • Normal and Elevated serum alanine transferase (ALT) levels
  • Positive serum HCV-RNA.
  • Aged between 18 and 65 years.
  • Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and additionally for participants treated with ribavirin, for 6 months (for woman) and 7 months (for man and his partner) after treatment completion

Exclusion Criteria:

  • Liver disease unrelated to HCV infection
  • Hemoglobin (Hgb) <12g/dL in women and <13g/dL in men; white blood cells (WBC) <3,000/uL; platelets (PLTs) <100,000/ul
  • Women with ongoing pregnancy or who are breast feeding
  • History of severe psychiatric disease, especially depression
  • History of neurologic disease, especially epilepsy
  • History or evidence of symptoms of severe cardiac, gastrointestinal and kidney disease
  • Positive anti-Human Immunodeficiency Virus (HIV) antibodies
  • Positive anti-nuclear antibodies (ANA) and/or Anti-Smooth Muscle Antibody (ASMA) (>1/80)
  • Positive Hepatitis B surface antigen (HBsAg)
  • History of having received any systemic anti-neoplastic or immunomodulatory treatment in the previous 6 months
  • History or other evidence of severe illness or any other conditions which would make the participants, in the opinion of investigator, unsuitable for the study (active drug addict except those under methadone treatment, thalassemic, dyalized included)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00686517     History of Changes
Other Study ID Numbers: P03552
Study First Received: May 27, 2008
Results First Received: December 22, 2011
Last Updated: August 1, 2014
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferons
Ribavirin
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014