NCT00039871

Brief Summary

The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,333

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2002

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 13, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2002

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 11, 2008

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

5.3 years

First QC Date

June 13, 2002

Results QC Date

September 29, 2008

Last Update Submit

March 7, 2017

Conditions

HepatitisHepatitis C, ChronicFibrosisLiver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Sustained Virologic Response (SVR) Rate

    Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)

    Assessed at end of 24 weeks posttreatment follow-up

Secondary Outcomes (2)

  • Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12

    24 weeks posttreatment

  • Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12

    24 weeks posttreatment

Study Arms (1)

Overall study population

EXPERIMENTAL
Biological: PegIntron (peginterferon alfa-2b; SCH 54031)Drug: REBETOL (ribavirin; SCH 18908)

Interventions

PegIntron (peginterferon alfa-2b; SCH 54031)BIOLOGICAL

PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks

Also known as: SCH 54031
Overall study population
REBETOL (ribavirin; SCH 18908)DRUG

REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks

Overall study population

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age at entry 18-65
  • Positive for Hepatitis C
  • Nonresponder to previous treatment (minimum of 3 months) with an alpha Interferon plus ribavirin
  • Liver biopsy demonstrating moderate to severe fibrosis or cirrhosis

You may not qualify if:

  • Any cause for the liver disease other than chronic hepatitis C
  • History or presence of complications of cirrhosis
  • Alcohol or illicit drug use or methadone treatment within the past 2 years
  • Treatment for chronic hepatitis C within the previous 6 months
  • Diseases or conditions that could interfere with the subject's participation in and completion of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Poynard T, Munteanu M, Colombo M, Bruix J, Schiff E, Terg R, Flamm S, Moreno-Otero R, Carrilho F, Schmidt W, Berg T, McGarrity T, Heathcote EJ, Goncales F, Diago M, Craxi A, Silva M, Boparai N, Griffel L, Burroughs M, Brass C, Albrecht J. FibroTest is an independent predictor of virologic response in chronic hepatitis C patients retreated with pegylated interferon alfa-2b and ribavirin in the EPIC(3) program. J Hepatol. 2011 Feb;54(2):227-35. doi: 10.1016/j.jhep.2010.06.038. Epub 2010 Sep 15.

    PMID: 21056496RESULT

MeSH Terms

Conditions

HepatitisHepatitis C, ChronicFibrosisLiver Cirrhosis

Interventions

peginterferon alfa-2bRibavirin

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesHepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2002

First Posted

June 14, 2002

Study Start

May 1, 2002

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

April 4, 2017

Results First Posted

December 11, 2008

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

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