Chronic Hepatitis CPhase 3PEGLIST CNCT00927290
Pioglitazone vs. Placebo in Association With Pegylated Interferon and Ribavirin in HCV Patients With Insulin Resistance
A Phase 3 study testing Pioglitazone in people with Chronic Hepatitis C and Insulin Resistance, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
Trial summary
The purpose of this study is to test whether the correction of insulin resistance with pioglitazone, will improve the response to antiviral treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C, Insulin Resistance
- What is being tested?
- Pioglitazone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2009to 6 Jul 2012
- Phase
- Phase 3
- 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
- 18 years old or older
- Chronic HCV infection documented by PCR with genotype HCV-1, 4, 5 or 6
- Naive Patient(never treated with antivirals for HCV)
- HOMA score higher than 2.5
- Patient for which the investigator decided to start antiviral treatment for chronic hepatitis C
Who cannot join
- Cardiovascular disease: heart failure stage NYHA II, III or IV, unstable angina, myocardial infarction in the previous year, cardiac surgery or stroke
- Alcohol consumption exceeding 40 g / day
- Decompensated liver disease: Child-Pugh B 8 or higher, or one of the following : bilirubin over 35 mol / L, TP below 50%, ascites, encephalopathy
- Hepatocellular carcinoma or any other neoplasm (except if in remission for > 5 years)
- Other documented chronic liver disease
- Insulin treated diabetes
Show all 12Show fewer
- HBV or HIV co-infection infection confirmed
- Thrombocytopenia below 50 000/mm ³; neutropenia below 750/mm ³ or hemoglobin below 11 g / dL
- Drug-induced steatosis(tamoxifen, glucocorticosteroids, amiodarone, tetracyclines).
- Bone marrow or solid organ transplantation
- Pregnancy or breastfeeding, or desire for pregnancy during the study period.
- Patients under legal protection or unable to express their consent
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Pitié Salpêtrière, Service d'hépatogastroentérologie
Paris, 75013
About this study
Official title: ANRS HC 22, PEGLIST-C, Multicenter, Randomized Controlled Trial of Pioglitazone vs. Placebo in Association With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C, Non 2 or 3 Genotypes and Insulin Resistance
The purpose of this study is to test whether the correction of insulin resistance with pioglitazone, will improve the response to antiviral treatment.
Read the detailed description
In patients infected with genotypes 1, 4, 5 and 6, the response rate to antiviral therapy remains suboptimal (less than one in two patients have a sustained virological response), which justifies the search for strategies optimizing the results of antiviral therapy. Some factors associated with non response have been identified. Among the modifiable factors, numerous series have shown that insulin resistance adversely impacts the rate of sustained virological response. The aim of this study is to determine whether the pharmacological correction of insulin resistance through therapy with glitazones restores higher rates of viral eradication and to determine the impact on the kinetics of viral response. Patients will be randomized to receive pioglitazone or placebo starting 4 months before initiating pegylated interferon and ribavirin and continued throughout the whole antiviral treatment period.
- Conditions
- Chronic Hepatitis C, Insulin Resistance
- Being tested
- Pioglitazone, Placebo
- Keywords
- hepatitis C; insulin resistance; glitazones; pioglitazone; steatosis; viral kinetics; antiviral response
- Medical subject headings
- Hepatitis C, Chronic, Insulin Resistance, Hepatitis C, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Pioglitazone, 45 mg QD (30 mg QD the first month)
PlaceboDrug
Placebo 45 mg QD (30 mg QD the first month)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Pioglitazone, 16 weeks before and during antiviral combination therapy Receives: Drug: Pioglitazone |
| 2 | Placebo comparator | Pioglitazone placebo, 16 weeks before and during antiviral combination therapy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in the HOMA score below 2 after 4 months of treatment with pioglitazone or placebo(at W16). The efficiency is defined as a higher proportion of subjects with HOMA <2 in the pioglitazone group than in the group treated with placebo pioglitazone.
Measured: W16
Secondary outcomes (1)
Kinetics of decrease in viral response to pegylated interferon. Early virological response rates. Rates of sustained virological response. Effect on steatosis
Measured: EVR at W16 and W28 SVR at W88
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study start3 Dec 2009
- Primary completion6 Jul 2012
- Study completion6 Jul 2012
Why it stopped: Suspension of use of medicine containing Pioglitazone by French regulatory agency
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vlad RATZIU, MD, PHD, Principal investigator, Hôpital Pitié--Salpêtrière, 83 Bd de l'Hôpital 75651 Paris cedex 13, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927290
- Sponsor's protocol ID
- 2008-006225-14
- Other IDs
- 2008
- Acronym
- PEGLIST C
- Status last verified
- Jan 2017
- First submitted
- 22 Jun 2009
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANRS HC 22, PEGLIST-C, Multicenter, Randomized Controlled Trial of Pioglitazone vs. Placebo in Association With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C, Non 2 or 3 Genotypes and Insulin Resistance
- ClinicalTrials.gov ID
- NCT00927290
- Acronym / sponsor ID
- PEGLIST C / 2008-006225-14
- Conditions
- Chronic Hepatitis C, Insulin Resistance
- Keywords
- hepatitis C; insulin resistance; glitazones; pioglitazone; steatosis; viral kinetics; antiviral response
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suspension of use of medicine containing Pioglitazone by French regulatory agency
- Enrolment
- 40 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Study start
- 3 Dec 2009 (actual)
- Primary completion
- 6 Jul 2012 (actual)
- Study completion
- 6 Jul 2012 (actual)
- First posted
- 24 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether the correction of insulin resistance with pioglitazone, will improve the response to antiviral treatment.
Detailed description
In patients infected with genotypes 1, 4, 5 and 6, the response rate to antiviral therapy remains suboptimal (less than one in two patients have a sustained virological response), which justifies the search for strategies optimizing the results of antiviral therapy. Some factors associated with non response have been identified. Among the modifiable factors, numerous series have shown that insulin resistance adversely impacts the rate of sustained virological response. The aim of this study is to determine whether the pharmacological correction of insulin resistance through therapy with glitazones restores higher rates of viral eradication and to determine the impact on the kinetics of viral response. Patients will be randomized to receive pioglitazone or placebo starting 4 months before initiating pegylated interferon and ribavirin and continued throughout the whole antiviral treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: PioglitazonePioglitazone, 16 weeks before and during antiviral combination therapy |
| 2 | Placebo comparator | Drug: PlaceboPioglitazone placebo, 16 weeks before and during antiviral combination therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old or older
- Chronic HCV infection documented by PCR with genotype HCV-1, 4, 5 or 6
- Naive Patient(never treated with antivirals for HCV)
- HOMA score higher than 2.5
- Patient for which the investigator decided to start antiviral treatment for chronic hepatitis C
Key exclusion criteria (12 listed)
- Cardiovascular disease: heart failure stage NYHA II, III or IV, unstable angina, myocardial infarction in the previous year, cardiac surgery or stroke
- Alcohol consumption exceeding 40 g / day
- Decompensated liver disease: Child-Pugh B 8 or higher, or one of the following : bilirubin over 35 mol / L, TP below 50%, ascites, encephalopathy
- Hepatocellular carcinoma or any other neoplasm (except if in remission for > 5 years)
- Other documented chronic liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PioglitazonePioglitazone, 45 mg QD (30 mg QD the first month) | Drug | 1 |
| PlaceboPlacebo 45 mg QD (30 mg QD the first month) | Drug | 2 |
Primary outcome
Decrease in the HOMA score below 2 after 4 months of treatment with pioglitazone or placebo(at W16). The efficiency is defined as a higher proportion of subjects with HOMA <2 in the pioglitazone group than in the group treated with placebo pioglitazone.
Time frame: W16
1 secondary outcome
Kinetics of decrease in viral response to pegylated interferon. Early virological response rates. Rates of sustained virological response. Effect on steatosis
Time frame: EVR at W16 and W28 SVR at W88
Results and safety
The study was stopped early (reason given: Suspension of use of medicine containing Pioglitazone by French regulatory agency). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vlad RATZIU, MD, PHD principal investigator
Hôpital Pitié--Salpêtrière, 83 Bd de l'Hôpital 75651 Paris cedex 13, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pioglitazone in people with Chronic Hepatitis C and Insulin Resistance, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 24 Jan 2017. 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 France. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Suspension of use of medicine containing Pioglitazone by French regulatory agency). Results are not available in the source record.
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?
Decrease in the HOMA score below 2 after 4 months of treatment with pioglitazone or placebo(at W16). The efficiency is defined as a higher proportion of subjects with HOMA <2 in the pioglitazone group than in the group treated with placebo pioglitazone. (time frame: W16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2017.