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Chronic Hepatitis CPhase 2NCT00433069

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

A Phase 2 study testing Pioglitazone, Interferon Alfa-2a and Ribavirin in people with Chronic Hepatitis C, run by University Hospital, Geneva at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis C
What is being tested?
Pioglitazone, Interferon Alfa-2a and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteSwitzerland
Study dates
Jan 2007to Jan 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Service de Gastroentérologie et d'Hépatologie, University Hospital

    Geneva, Canton of Geneva, 1211

Other trials in Switzerland

About this study

Official title: 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.

Read the detailed description

Insulin resistance and diabetes are major disease modifiers in chronic hepatitis C, as they increase liver fibrogenesis and reduce the rate of response to antivirals. Regarding the latter, a previous study showed that a sustained virological response (SVR) occurred in about one third of patients with genotype 1 and insulin resistance (measured as homeostasis assessment of insulin resistance, HOMA-IR > 2) vs. two thirds of genotype 1 patients without insulin resistance. These findings were independently confirmed by other studies and extended to non-responders with genotypes 2, 3 and 4. Thus, we suggested that insulin resistance should be corrected in patients with chronic hepatitis C not responding to currently available antiviral treatment, in order to improve response to retreatment. The modalities of this intervention, however, have not been established. In addition, the optimal HOMA-IR score to be attained has not been identified. To assess this point, we planned a prospective, multicenter study to investigate the efficacy and safety of the insulin-sensitizer pioglitazone (ActosTM, Takeda Pharma AG, Lachen, Switzerland) 15 mg QD, added to the pegylated interferon-α2a (PEG-IFN-α2a) (PegasysTM, Roche Pharma Schweiz AG, Reinach, Switzerland) 180 μg QW/ribavirin (CopegusTM, Roche) 1000-1200 mg QD combination therapy in chronic hepatitis C patients who had previously failed to respond (i.e. had detectable serum HCV RNA after 12 weeks of therapy) to a pegylated interferon-α/ribavirin combination without the insulin-sensitizer. All patients had a baseline HOMA-IR score >2 as additional inclusion criterion, because this was the threshold discriminating responders from non-responders in previous works. Diabetic patients were excluded.

Being tested
Pioglitazone, Interferon Alfa-2a, Ribavirin
Keywords
Chronic hepatitis C, Insulin resistance, Pioglitazone, Non-responders
Medical subject headings
Hepatitis C, Chronic, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PioglitazoneDrug

    Also called Actos

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

  • Interferon Alfa-2aDrug

    Also called Pegasys

    Standard of care for chronic hepatitis C

  • RibavirinDrug

    Also called Copegus

    Standard of care for chronic hepatitis C

Study groups in NCT00433069
Study groupRoleWhat they receive
InterventionExperimentalPioglitazone 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
Receives: Drug: Pioglitazone; Drug: Interferon Alfa-2a; Drug: Ribavirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Early virological response

    Measured: Week 12 of triple combined therapy

Secondary outcomes (3)

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

    Measured: Week 2, 24 and 48 of therapy

  2. Changes (vs. baseline) of body weight, HOMA score, after 4, 12 and 48 weeks of therapy and after 24 weeks of follow-up

    Measured: Weeks 4, 12 and 48 of therapy

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

    Measured: Weeks 12 and 48 of therapy; week 24 of FU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionDec 2007
  4. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00433069
Sponsor's protocol ID
GE-DMI-05-116
Status last verified
May 2015
First submitted
8 Feb 2007
Last updated
28 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15765399

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pioglitazone, Interferon Alfa-2a and Ribavirin in people with Chronic Hepatitis C, run by University Hospital, Geneva at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early virological response (time frame: Week 12 of triple combined therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00433069, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.

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