Infergen, Ribavirin & Avandia in Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin

NCT00207402 | Completed Phase 4

• 1 other identifier: C2005.143
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Genotype 1 hepatitis C virus (HCV) patients who did not respond (did not lose virus during treatment) or relapsed (virus went away on treatment but came back after treatment was stopped) after treatment with at least twelve weeks of a pegylated (long-acting) interferon and ribavirin will be considered for this study. There are two purposes to this study: first, to determine how rosiglitazone, a medicine used to treat diabetes, affects the HCV viral load; and second, to determine if treatment of insulin resistance with rosiglitazone prior to therapy for HCV will improve sustained virologic response (loss of virus that continues beyond six months after completion of HCV therapy) to HCV therapy.

Conditions

Hepatitis C

Keywords

Hepatitis C; Insulin resistance

Outcome Measures

Primary Outcomes (1)

• There is change in viral kinetics with improvement of insulin sensitivity

  104 days

Secondary Outcomes (1)

• There is significant improvement in the SVR obtained when treating insulin resistant patients with the insulin sensitizing medication, Avandia, prior to and during treatment with Infergen and ribavirin when compared to Infergen

  72 weeks

Study Arms (2)

rosiglitazone

ACTIVE COMPARATOR

Treatment with rosiglitazone 4 mg twice a day for 3 months prior to and during the course of 48 weeks of treatment with interferon alfacon-1 15mcg/0.5ml SQ daily and weight-based ribavirin.

Drug: rosiglitazone

No Avandia

NO INTERVENTION

Monitoring period without rosiglitazone for 3 months prior to 48 weeks of interferon alfacon-1 15mcg/0.5ml SQ daily and weight-based ribavirin

Interventions

rosiglitazone DRUG

Infergen 15mcg/ d Avandia qd Ribavirin bid

Also known as: Infergen (interferon alfacon-1), Avandia (rosiglitazone), Ribavirin

rosiglitazone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants willing to give written informed consent and able to adhere to dose and visit schedules.
• Adult participants 18 years of age or older of either gender or any race. Participants who are over 65 years of age must be in generally good health.
• HCV-antibody (Ab) or HCV-RNA positive by polymerase chain reaction (PCR) for at least 6 months.
• Serum positive for HCV-RNA by PCR assay.
• Subjects must be previous nonresponders or relapsers on pegylated interferon and ribavirin therapy.
• Liver biopsy within 24 months prior to enrollment into the protocol.
• Compensated liver disease with the following minimum hematological, biochemical, and serologic criteria at the Screening Visit (WNL = within normal limits):
• Hemoglobin values of \< 12 gm/dL for females and \< 13 gm/dL for males.
• White blood cells (WBC) \< 3,000/mm3
• Neutrophil count \< 1,500/mm3
• Platelets \< 65,000/mm3
• Direct bilirubin, within 20% of upper limits of normal (ULN)
• Indirect bilirubin, (WNL) (unless non-hepatitis related factors such as Gilbert's disease explain an indirect bilirubin rise. In such cases indirect bilirubin must be \< 3.0 mg/dL \[\< 51.3 µmol/L\]).
• Albumin \> 3 gm/dL
• Serum creatinine \< 20% of ULN

You may not qualify if:

• Inability or unwillingness to provide informed consent or abide by the requirements of the study
• Participants on insulin are excluded.
• Participants on metformin or another thiazolidinedione must have a three-month wash-out period to be considered for the study.
• Women who are pregnant or breast-feeding
• Males whose female partner is pregnant
• No other thiazolidinedione after liver biopsy and/or during the entire study (other than those subjects randomized to receive rosiglitazone during the study)
• Hepatitis C of non-genotype 1
• Suspected hypersensitivity to interferon, ribavirin, or rosiglitazone
• Any cause for liver disease other than chronic hepatitis C, insulin resistance, or non-alcoholic fatty liver disease (NAFLD), including but not limited to:
• Hemochromatosis
• Alpha-1 antitrypsin deficiency
• Co-infection with hepatitis B virus (HBV) \[serum hepatitis B surface antigen (HBsAg) positive\]
• Wilson's disease
• Autoimmune hepatitis
• Alcoholic liver disease (consumption of greater than 2 drinks a day on average)

Sponsors & Collaborators

• Brooke Army Medical Center: lead
• InterMune: collaborator

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Conditions

Hepatitis C; Insulin Resistance

Interventions

Rosiglitazone; interferon alfacon-1; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Stephen A Harrison, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

• Shane Mills, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: July 1, 2010
• Last Updated: February 14, 2012

Record last verified: 2012-02

Locations

US (1)