Back to results

Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059) (START 4)

Primary Purpose

Hepatitis C, Chronic

Status

Terminated

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

PEG-IFN alfa-2b

ribavirin

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participant is ≥40 kg and ≤120 kg weight
Participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.
Previously documented CHC genotype 4 infection
Liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology and with hepatic fibrosis scores (F0, F1, F2, F3).

Exclusion Criteria:

Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus
Treatment for hepatitis C with any investigational medication
Treatment with any investigational drug within 30 days of the screening visit
Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
Autoimmune hepatitis or a history of autoimmune disease
Hepatic fibrosis score F4
Severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
Autoimmune hepatitis or a history of autoimmune disease
Thyroid disease uncontrolled with conventional treatment
Epilepsy and/or compromised central nervous system (CNS) function

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

44 Weeks of PEG-IFN alfa-2b + RBV

20 Weeks of PEG-IFN alfa-2b + RBV

Arm Description

Participants achieving RVR at 4 weeks of treatment will receive 44 additional weeks of Peg-IFN Alfa-2b + RBV.

Participants achieving RVR at 4 weeks of treatment will receive 20 additional weeks of Peg-IFN Alfa-2b + RBV.

Outcomes

Primary Outcome Measures

Number of Participants Achieving Sustained Virologic Response (SVR)

SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.

Secondary Outcome Measures

Full Information

NCT ID

NCT01606800

First Posted

May 24, 2012

Last Updated

September 27, 2018

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01606800

Brief Title

Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059)

Acronym

START 4

Official Title

Randomized Open Label Study to Assess the Efficacy and Safety of Short Course Therapy (24 Weeks) With Peginterferon Alpha-2b and Ribavirin for Chronic Hepatitis C (Genotype 4) Patients Who Achieve a Rapid Virological Response (HCV -RNA Undetectable at Week 4 of Treatment)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Terminated

Why Stopped

The trial was terminated due to change in new standard of therapy during the study period.

Study Start Date

January 1, 2013 (Actual)

Primary Completion Date

January 26, 2015 (Actual)

Study Completion Date

January 26, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.

Detailed Description

Participants who achieved RVR after 4 weeks of PEG-INF alfa-2b plus RBV treatment were randomized to receive either 20 or 44 weeks of continued therapy, for a total of 24 or 48 weeks total of PEG-INF plus RBV therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

44 Weeks of PEG-IFN alfa-2b + RBV

Arm Type

Experimental

Arm Description

Participants achieving RVR at 4 weeks of treatment will receive 44 additional weeks of Peg-IFN Alfa-2b + RBV.

Arm Title

20 Weeks of PEG-IFN alfa-2b + RBV

Arm Type

Experimental

Arm Description

Participants achieving RVR at 4 weeks of treatment will receive 20 additional weeks of Peg-IFN Alfa-2b + RBV.

Intervention Type

Drug

Intervention Name(s)

PEG-IFN alfa-2b

Intervention Description

Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week

Intervention Type

Drug

Intervention Name(s)

ribavirin

Intervention Description

Ribavirin 200 mg capsules administered orally daily based on weight

Primary Outcome Measure Information:

Title

Number of Participants Achieving Sustained Virologic Response (SVR)

Description

SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.

Time Frame

At 24 weeks after the completion of therapy (up to 72 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant is ≥40 kg and ≤120 kg weight Participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations. Previously documented CHC genotype 4 infection Liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology and with hepatic fibrosis scores (F0, F1, F2, F3). Exclusion Criteria: Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus Treatment for hepatitis C with any investigational medication Treatment with any investigational drug within 30 days of the screening visit Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy Autoimmune hepatitis or a history of autoimmune disease Hepatic fibrosis score F4 Severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months Autoimmune hepatitis or a history of autoimmune disease Thyroid disease uncontrolled with conventional treatment Epilepsy and/or compromised central nervous system (CNS) function

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

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

Available IPD and Supporting Information:

Available IPD/Information Type

CSR Synopsis

Available IPD/Information URL

http://www.merck.com/clinical-trials/study.html?id=8908B-059&kw=8908B-059&tab=access

Learn more about this trial

We'll reach out to this number within 24 hrs