Retreatment of Chronic Hepatitis C Non-Responders With Pegylated Interferon Alpha Plus Ribavirin Plus Pioglitazone

This study has suspended participant recruitment.
(The tested combination was ineffective.)
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00433069
First received: February 8, 2007
Last updated: April 10, 2008
Last verified: April 2008

February 8, 2007
April 10, 2008
January 2007
July 2007   (final data collection date for primary outcome measure)
Early virological response [ Time Frame: Week 12 of triple combined therapy ] [ Designated as safety issue: Yes ]
  • Initial virological response (HCV RNA in serum at12 weeks of therapy)
  • Sustained virological response (undetectable serum HCV RNA at the end of a 24 week treatment-free follow-up)
Complete list of historical versions of study NCT00433069 on ClinicalTrials.gov Archive Site
  • Undetectable serum HCV RNA after 4, 24 weeks and 48 weeks of therapy [ Time Frame: Week 2, 24 and 48 of therapy ] [ Designated as safety issue: Yes ]
  • Changes (vs. baseline) of body weight, HOMA score, after 4, 12 and 48 weeks of therapy and after 24 weeks of follow-up [ Time Frame: Weeks 4, 12 and 48 of therapy ] [ Designated as safety issue: Yes ]
  • Improvement (vs. baseline) of glucose tolerance parameters after 12 and 48 weeks of therapy and after 24 weeks of follow-up [ Time Frame: Weeks 12 and 48 of therapy; week 24 of FU ] [ Designated as safety issue: Yes ]
  • Undetectable serum HCV RNA after 4, 24 weeks and 48 weeks of therapy
  • Changes (vs. baseline) of body weight, HOMA score, after 4, 12 and 48 weeks of therapy and after 24 weeks of follow-up
  • Improvement (vs. baseline) of glucose tolerance parameters after 12 and 48 weeks of therapy and after 24 weeks of follow-up
Not Provided
Not Provided
 
Retreatment of Chronic Hepatitis C Non-Responders With Pegylated Interferon Alpha Plus Ribavirin Plus Pioglitazone
A Pilot Study of Treatment With Pegylated Interferon-Alpha2a, Ribavirin and Insulin Sensitizer Pioglitazone of Insulin Resistance (With the Exception of Diabetes) in Hepatitis C Virus Infection (The INSPIRED HCV Study)

The aim of this study is to investigate the efficacy and safety of an insulin-sensitizer (Actos) added to a standard Pegasys/Copegus combination therapy of chronic hepatitis C in patients who have previously failed a pegylated-interferon-alpha / ribavirin combination without the insulin sensitizer. The primary endpoint is the initial virological response (level of HCV RNA in serum) as evaluated after 12 weeks of triple therapy.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: Pioglitazone
    Increase response to interferon alpha plus ribavirin by increasing insulin sensitivity
  • Drug: Increase response to interferon alpha plus ribavirin by increasing insulin sensitivity
    Pioglitazone 15 mg PD will be given to chronic hepatitis C patients in addition to peginterferon-alpha2a and ribavirin (Standard of Care, SOC) for 12 weeks to improve virological response. All recruited patients will be previous non-responders to SOC.
Not Provided
Romero-Gomez M, Del Mar Viloria M, Andrade RJ, Salmeron J, Diago M, Fernandez-Rodriguez CM, Corpas R, Cruz M, Grande L, Vazquez L, Munoz-De-Rueda P, Lopez-Serrano P, Gila A, Gutierrez ML, Perez C, Ruiz-Extremera A, Suarez E, Castillo J. Insulin resistance impairs sustained response rate to peginterferon plus ribavirin in chronic hepatitis C patients. Gastroenterology. 2005 Mar;128(3):636-41.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
35
July 2007
July 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed chronic hepatitis C as per liver biopsy performed during the 12 months prior to enrollment (except patients with histologically proven cirrhosis or a Actitest/Fibrotest assay, or a Fibroscan performed during the 12 months prior to enrollment)
  • HCV RNA in serum >600 IU/ml
  • elevated ALT
  • HCV genotypes 1, 2, 3 or 4
  • failure to respond to a prior treatment with a pegylated interferon alpha + ribavirin
  • HOMA score > 2.00
  • documentation that sexually active female patients of childbearing potential are practicing adequate contraception (intrauterine device, oral contraceptives, progesterone implanted rods, medroxyprogesterone acetate, surgical sterilization plus a barrier method [diaphragm + spermicide] or monogamous relationship with a male partner who has had a vasectomy or is using a condom + spermicide) during the treatment period and for 6 months after discontinuation of therapy. A serum pregnancy test obtained at entry prior to the initiation of treatment must be negative. Female patients must not be breast feeding
  • documentation that sexually active male patients are practicing acceptable methods of contraception (vasectomy, use of a condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 6 months after discontinuation of therapy
  • willingness and capability to give written informed consent and to comply with the requirements of the trial

Exclusion Criteria:

  • history of diabetes (ADA definition)
  • history of significant cardiovascular disease (NYHA III) including but not limited to uncontrolled hypertension, angina pectoris, myocardial infarction, coronary artery surgery and congestive heart failure
  • HBsAg and/or HIV
  • auto-immune disease, including auto-immune hepatitis
  • alcohol consumption exceeding 40 grams per day
  • hepatocellular carcinoma
  • renal insufficiency (serum creatinine levels above 200 micromol/l)
  • unconjugated bilirubin blood level > 100 micromol/l
  • glutamyl transferase > 20 times the ULN
  • prothrombin time < 60% of control (except in case of oral anti-coagulant therapy)
  • neutrophil count < 1.5 G/L
  • platelet count < 70 G/L
  • hemoglobin <120 g/L
  • organ or bone marrow transplantation
  • current neoplasm and/or anti-tumor chemotherapy
  • current hepatic arterial thrombosis
  • pregnant or breast feeding women; child bearing potential women without adequate contraception throughout the course of therapy
  • psychosis or anti-depressant therapy for uncontrolled clinical depression
  • epilepsy
  • clinically significant retinal abnormalities
  • thyroid dysfunction
  • drug abuse or substitution therapy during the 12 months prior to inclusion
  • interstitial pneumonitis
  • previous auto-immune hemolysis and all causes of chronic hemolysis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00433069
GE-DMI-05-116, The SASL 22 Study
Not Provided
Prof. Francesco Negro, University Hospital of Geneva
University Hospital, Geneva
Not Provided
Principal Investigator: Francesco Negro, Prof University of Geneva, Switzerland
University Hospital, Geneva
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP