NCT00433069

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

January 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

February 8, 2007

Last Update Submit

May 27, 2015

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis CInsulin resistancePioglitazoneNon-responders

Outcome Measures

Primary Outcomes (1)

  • Early virological response

    Week 12 of triple combined therapy

Secondary Outcomes (3)

  • Undetectable serum HCV RNA after 4, 24 weeks and 48 weeks of therapy

    Week 2, 24 and 48 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

    Weeks 4, 12 and 48 of therapy

  • Improvement (vs. baseline) of glucose tolerance parameters after 12 and 48 weeks of therapy and after 24 weeks of follow-up

    Weeks 12 and 48 of therapy; week 24 of FU

Study Arms (1)

Intervention

EXPERIMENTAL

Pioglitazone 15 mg QD + pegylated interferon Alfa-2a 180 μg QW + ribavirin 1000-1200 mg QD for 12 weeks, to be continued to a total of 48 weeks in case of complete early virological response, defined as undetectable serum HCV RNA after 12 weeks of triple therapy

Drug: PioglitazoneDrug: Interferon Alfa-2aDrug: Ribavirin

Interventions

PioglitazoneDRUG

Increase early virological response to pegylated interferon alpha plus ribavirin by increasing insulin sensitivity

Also known as: Actos
Intervention
Interferon Alfa-2aDRUG

Standard of care for chronic hepatitis C

Also known as: Pegasys
Intervention
RibavirinDRUG

Standard of care for chronic hepatitis C

Also known as: Copegus
Intervention

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Gastroentérologie et d'Hépatologie, University Hospital

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (1)

  • 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. doi: 10.1053/j.gastro.2004.12.049.

    PMID: 15765399BACKGROUND

MeSH Terms

Conditions

Hepatitis C, ChronicInsulin Resistance

Interventions

PioglitazoneInterferon alpha-2peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsInterferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsRibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Francesco Negro, Prof

    University of Geneva, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2007

First Posted

February 9, 2007

Study Start

January 1, 2007

Primary Completion

December 1, 2007

Study Completion

January 1, 2008

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

CH(1)