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

March 8, 2017 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • SCH 54031, PegIntron
Drug: Ribavirin
Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks
Other Names:
  • SCH 18908, Rebetol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.
Evaluated at the end of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).

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.
At the end of treatment (either 12 weeks or 24 weeks depending on randomization).
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).
LTR was obtained if serum HCV RNA level at the end of 12-month follow-up was <15 IU/mL.
At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization).
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.
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.
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.
Number of Participants With Rapid Virologic Response (RVR)
Time Frame: Evaluated at 2 and 4 weeks of treatment

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.
Evaluated at 2 and 4 weeks of treatment
Number of Peripheral Blood Mononuclear Cells (PBMCs)
Time Frame: Treatment Weeks 2, 4, 8, and 12
Cellular Differentiation Cluster Antigen 8-Positive (CD8+) PBMCs were measured at randomization, Treatment Weeks 2, 4, 8, and 12.
Treatment Weeks 2, 4, 8, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Bioikos Ambiente Srl

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 27, 2008

First Posted (Estimate)

May 30, 2008

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

March 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P03552

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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