NCT00725751

Brief Summary

Although injection drug users represent the majority of new and existing cases of infection with hepatitis C virus (HCV), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection. On the basis of a small but growing body of evidence showing that injection drug users can undergo treatment for HCV infection successfully, the 2002 NIH Consensus Statement on Hepatitis C has recommended that substance users be treated for HCV infection on a case-by-case basis. In this study, all patients will receive pegylated interferon alfa-2b (PegIFN-2b) and ribavirin according to European labeling; one cohort of participants will also be receiving substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
353

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Typical duration for all trials

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

September 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 23, 2012

Completed
Last Updated

October 2, 2015

Status Verified

October 1, 2015

Enrollment Period

3.5 years

First QC Date

July 25, 2008

Results QC Date

March 23, 2012

Last Update Submit

October 1, 2015

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin

    For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.

    24 to 48 weeks

Secondary Outcomes (2)

  • Number of Participants Who Achieved Sustained Virologic Response (SVR)

    24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype)

  • Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy

    Day 1

Study Arms (2)

PegIFN-2b/ribavirin with substitution therapy

Participants in this cohort received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)

Biological: Pegylated interferon alfa-2b (PegIFN-2b)Drug: Ribavirin

PegIFN-2b/ribavirin without substitution therapy

Participants in this cohort received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)

Biological: Pegylated interferon alfa-2b (PegIFN-2b)Drug: Ribavirin

Interventions

Pegylated interferon alfa-2b (PegIFN-2b)BIOLOGICAL

PegIFN-2b administered according to European labeling.

Also known as: PegIntron, SCH 54031
PegIFN-2b/ribavirin with substitution therapyPegIFN-2b/ribavirin without substitution therapy
RibavirinDRUG

Ribavirin administered according to European labeling.

Also known as: Rebetol, SCH 18908
PegIFN-2b/ribavirin with substitution therapyPegIFN-2b/ribavirin without substitution therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients receiving treatment for hepatitis C with/without substitution therapy at sites in Austria.

You may qualify if:

  • Adult patients with hepatitis C

You may not qualify if:

  • According to the products' European labeling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2bRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic 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
1-800-672-6372

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2008

First Posted

July 30, 2008

Study Start

September 1, 2007

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

October 2, 2015

Results First Posted

April 23, 2012

Record last verified: 2015-10