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Infergen and Ribavirin Treatment of Patients With HCV Who Achieved Partial Response to Peginterferon-alfa and Ribavirin (ENHANCE)

Primary Purpose

Hepatitis C

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Infergen and ribavirin

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Chronic Hepatitis C, Liver, Pegylated, Interferon, Ribavirin, Combination, Nonresponder, Relapser, HCV, Infergen, SVR

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, at least 18 years of age and no older than 65 years with compensated chronic HCV infection based on a history of positive serum anti-HCV antibody and/or HCV RNA
Diagnosed with HCV Genotype 1, 4, 5 or 6 as determined during the screening visit
The starting doses in the initial treatment must have been 1.5 μg/kg/week PEG-Intron or 180 μg/week Pegasys, and 1000/1200 mg/day ribavirin based on body weight. Patients must have been at least 80% compliant during the initial peginterferon/ribavirin therapy, per patient account.
Liver biopsy indicating F0-F4 must be performed within 3 years prior to screening. Documentation of the results of the biopsy must be available. If documentation is not available, a liver biopsy must be performed during the screening period. (A maximum of 10 patients in each of the three treatment groups will be patients with a fibrosis score of F4)
Documented partial response after 12 weeks of treatment as a therapy-naive patient with one course of peginterferon alfa-2a (PEGASYS) and Ribavirin or peginterferon alfa-2b (Peg-INTRON) and Ribavirin

Exclusion Criteria:

Detectable HCV RNA after 12 weeks if initial peginterferon alfa/ribavirin therapy and <2 log decrease in HCV RNA at Week 12 from baseline.
HCV Genotype 2 or 3
Severe neuropsychiatric disorder.
History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease.
Known HIV infection or positive HIV at screening.
Pregnant or breast-feeding patients.
Underlying autoimmune disease

Sites / Locations

Atlantic Gastroenterology Associates
Tulane University School of Medicine
Caroline Digestive Health Associates
Liver Institute at Methodist Dallas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Infergen 15 ug QD plus RBV for 36 weeks

Infergen 15 ug QD plus RBV for 48 weeks

Outcomes

Primary Outcome Measures

To evaluate the proportion of patients with a sustained viral response (SVR) defined as undetectable serum HCV RNA at the end of the 24 week post-treatment follow-up period.

Secondary Outcome Measures

Compare proportion of patients with SVR after switching treatment with Infergen/Ribavirin for 48 weeks versus those treated for 36 weeks

Full Information

NCT ID

NCT00456248

First Posted

April 2, 2007

Last Updated

October 11, 2012

Sponsor

Kadmon Corporation, LLC

1. Study Identification

Unique Protocol Identification Number

NCT00456248

Brief Title

Infergen and Ribavirin Treatment of Patients With HCV Who Achieved Partial Response to Peginterferon-alfa and Ribavirin

Acronym

ENHANCE

Official Title

Phase 4 Study Using Infergen and Ribavirin in Patients With Chronic Hepatitis C Virus Who Achieved Partial Response to Peginterferon-alfa and Ribavirin Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Terminated

Why Stopped

slow enrollment

Study Start Date

February 2007 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kadmon Corporation, LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a 60-to-72 week multicenter study to evaluate Infergen and Ribavirin in patients with Chronic Hepatitis C Virus after partial response to treatment using peginterferon-alfa and Ribavirin therapy. The study will be conducted at approximately 50 sites across the United States.

6. Conditions and Keywords

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

Hepatitis C

Keywords

Chronic Hepatitis C, Liver, Pegylated, Interferon, Ribavirin, Combination, Nonresponder, Relapser, HCV, Infergen, SVR

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Infergen 15 ug QD plus RBV for 36 weeks

Arm Title

Arm Type

Experimental

Arm Description

Infergen 15 ug QD plus RBV for 48 weeks

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Infergen and ribavirin

Intervention Description

Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks

Primary Outcome Measure Information:

Title

To evaluate the proportion of patients with a sustained viral response (SVR) defined as undetectable serum HCV RNA at the end of the 24 week post-treatment follow-up period.

Time Frame

1.5 years

Secondary Outcome Measure Information:

Title

Compare proportion of patients with SVR after switching treatment with Infergen/Ribavirin for 48 weeks versus those treated for 36 weeks

Time Frame

1.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, at least 18 years of age and no older than 65 years with compensated chronic HCV infection based on a history of positive serum anti-HCV antibody and/or HCV RNA Diagnosed with HCV Genotype 1, 4, 5 or 6 as determined during the screening visit The starting doses in the initial treatment must have been 1.5 μg/kg/week PEG-Intron or 180 μg/week Pegasys, and 1000/1200 mg/day ribavirin based on body weight. Patients must have been at least 80% compliant during the initial peginterferon/ribavirin therapy, per patient account. Liver biopsy indicating F0-F4 must be performed within 3 years prior to screening. Documentation of the results of the biopsy must be available. If documentation is not available, a liver biopsy must be performed during the screening period. (A maximum of 10 patients in each of the three treatment groups will be patients with a fibrosis score of F4) Documented partial response after 12 weeks of treatment as a therapy-naive patient with one course of peginterferon alfa-2a (PEGASYS) and Ribavirin or peginterferon alfa-2b (Peg-INTRON) and Ribavirin Exclusion Criteria: Detectable HCV RNA after 12 weeks if initial peginterferon alfa/ribavirin therapy and <2 log decrease in HCV RNA at Week 12 from baseline. HCV Genotype 2 or 3 Severe neuropsychiatric disorder. History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease. Known HIV infection or positive HIV at screening. Pregnant or breast-feeding patients. Underlying autoimmune disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mitchell L Schiffman, MD

Organizational Affiliation

Virginia Commonwealth University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Atlantic Gastroenterology Associates

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

Tulane University School of Medicine

City

New Orleans

State/Province

Louisiana

Country

United States

Facility Name

Caroline Digestive Health Associates

City

Harrisburg

State/Province

North Carolina

Country

United States

Facility Name

Liver Institute at Methodist Dallas

City

Dallas

State/Province

Texas

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Infergen and Ribavirin Treatment of Patients With HCV Who Achieved Partial Response to Peginterferon-alfa and Ribavirin

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