Hepatitis CPhase 2NCT01157975
Study the Relationship Between Obesity and Hepatitis C Replication
A Phase 2 study testing Pioglitazone and Prednisone in people with Hepatitis C, run by University of California, San Diego at 2 sites in 2 countries.
Trial summary
Patients with chronic hepatitis C viral infection (HCV) and with a BMI greater than 25Kg/m2 are refractory to medical treatment. Also, HCV replication seems to be affected when modeling insulin resistance in replicon cell culture systems. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Pioglitazone and Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2008to Sep 2014
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Infection with HCV genotype 1 or 4 (subjects infected with multiple genotypes are not eligible)
- BMI greater than 25 Kg/m2
- HCV-infected subjects naïve to treatment: subjects who either have never been treated for HCV infection or who previously received HCV treatment ending more than 3 months prior to enrollment for not longer than 2 weeks
- Plasma HCV RNA concentration of >10,000 IU/mL at the screening evaluation
Who cannot join
- Previous intolerance to Pioglitazone, Rosiglitazone, Troglitazone or corticosteroids
- Women who are pregnant or breastfeeding
- History of diabetes mellitus requiring treatment other than diet
- Decompensated liver disease or other known causes of liver disease including, but not limited to autoimmune hepatitis, Wilson's disease, hemochromatosis, primary biliary cirrhosis, schistosomiasis, sclerosing cholangitis, alcohol- or drug-induced liver disease, or alpha-one antitrypsin deficiency
- Concurrent hepatitis B virus (HBV) infection
- Known immunodeficiency disease, autoimmune disorders or active gastrointestinal disease
Show all 10Show fewer
- Abuse of alcohol or illicit drugs within 6 months before enrollment
- Use of an investigational drug within 4 weeks before the screening visit or during the screening period.
- Use of systemic immunosuppressants
- History of poorly controlled psychiatric disease or poorly controlled pulmonary disease
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of California at San Diego Hospitals
San Diego, California, 92037
About this study
Official title: A Randomized, Partially Blinded, Pilot Study of the Effects of Pioglitazone on HCV RNA in Overweight Subjects With Chronic HCV Genotypes 1 or 4 Infection.
Patients with chronic hepatitis C viral infection (HCV) and with a BMI greater than 25Kg/m2 are refractory to medical treatment. Also, HCV replication seems to be affected when modeling insulin resistance in replicon cell culture systems.
PPARg -agonist (Pioglitazone) is effective in controlling liver inflammation in obese subjects with non-alcoholic steatohepatitis (NASH) and also improving insulin sensitivity. Therefore, we hypothesize that improving insulin resistance and /or inflammation may affect HCV replication and viral kinetics. Independently of PPARg pathways, Prednisone may increase HCV viral kinetics. .
Read the detailed description
This is a randomized, two arm clinical trial. The investigators performing the primary and secondary endpoints are blinded to subject identifiers and arm identifiers.
Subject's screening for HCV Genotype 4 started in Agouza Hospital in July 2010 and ended in February, 2011. No recruitment has occurred for HCV Genotype 1.
- Conditions
- Hepatitis C
- Being tested
- Pioglitazone, Prednisone
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called ACTOS
Pioglitazone will be taken at a dose of 30 mg for up to 14 days
PrednisoneDrug
Prednisone will be taken at a dose of 40 mg for up to 4 days
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Experimental | Not described Receives: Drug: Pioglitazone |
| Prednisone | Experimental | Not described Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV RNA
Only in the Pioglitazone group
Measured: 2 weeks
Secondary outcomes (3)
HCV RNA
Only in the Prednisone group
Measured: Day 4
Serum indicators of insulin resistance (fasting glucose, insulin, lipids and serum retinol binding protein-4); adiponectins and inflammatory cytokines.
Measured: Day 14 (Pioglitazone) and Day 4 (Prednisone)
ALT and AST
Measured: Day 14 (Pioglitazone) and Day 4 (Prednisone)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startOct 2008
- Primary completionFeb 2014
- Study completionSep 2014
Why it stopped: Study was completed in another site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Chojkier, University of California, San Diego
- Investigators
- Mario Chojkier, MD, Principal investigator, UCSDMartina Buck, PhD, Principal investigator, UCSDHesham Elkhayat, MD, Principal investigator, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157975
- Sponsor's protocol ID
- 060913
- Status last verified
- Nov 2019
- First submitted
- 6 Jul 2010
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Chojkier M, Elkhayat H, Sabry D, Donohue M, Buck M. Pioglitazone decreases hepatitis C viral load in overweight, treatment naive, genotype 4 infected-patients: a pilot study. PLoS One. 2012;7(3):e31516. doi: 10.1371/journal.pone.0031516. Epub 2012 Mar 7.
PubMed 22412837
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Partially Blinded, Pilot Study of the Effects of Pioglitazone on HCV RNA in Overweight Subjects With Chronic HCV Genotypes 1 or 4 Infection.
- ClinicalTrials.gov ID
- NCT01157975
- Acronym / sponsor ID
- 060913
- Conditions
- Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was completed in another site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Oct 2008 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 8 Jul 2010 (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.
Patients with chronic hepatitis C viral infection (HCV) and with a BMI greater than 25Kg/m2 are refractory to medical treatment. Also, HCV replication seems to be affected when modeling insulin resistance in replicon cell culture systems.
PPARg -agonist (Pioglitazone) is effective in controlling liver inflammation in obese subjects with non-alcoholic steatohepatitis (NASH) and also improving insulin sensitivity. Therefore, we hypothesize that improving insulin resistance and /or inflammation may affect HCV replication and viral kinetics. Independently of PPARg pathways, Prednisone may increase HCV viral kinetics. .
Detailed description
This is a randomized, two arm clinical trial. The investigators performing the primary and secondary endpoints are blinded to subject identifiers and arm identifiers.
Subject's screening for HCV Genotype 4 started in Agouza Hospital in July 2010 and ended in February, 2011. No recruitment has occurred for HCV Genotype 1.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Experimental | Drug: Pioglitazone |
| Prednisone | Experimental | Drug: Prednisone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Infection with HCV genotype 1 or 4 (subjects infected with multiple genotypes are not eligible)
- BMI greater than 25 Kg/m2
- HCV-infected subjects naïve to treatment: subjects who either have never been treated for HCV infection or who previously received HCV treatment ending more than 3 months prior to enrollment for not longer than 2 weeks
- Plasma HCV RNA concentration of >10,000 IU/mL at the screening evaluation
Key exclusion criteria (10 listed)
- Previous intolerance to Pioglitazone, Rosiglitazone, Troglitazone or corticosteroids
- Women who are pregnant or breastfeeding
- History of diabetes mellitus requiring treatment other than diet
- Decompensated liver disease or other known causes of liver disease including, but not limited to autoimmune hepatitis, Wilson's disease, hemochromatosis, primary biliary cirrhosis, schistosomiasis, sclerosing cholangitis, alcohol- or drug-induced liver disease, or alpha-one antitrypsin deficiency
- Concurrent hepatitis B virus (HBV) infection
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 |
|---|---|---|
| PioglitazoneAlso: ACTOSPioglitazone will be taken at a dose of 30 mg for up to 14 days | Drug | Pioglitazone |
| PrednisonePrednisone will be taken at a dose of 40 mg for up to 4 days | Drug | Prednisone |
Primary outcome
HCV RNA
Time frame: 2 weeks
Only in the Pioglitazone group
3 secondary outcomes
HCV RNA
Time frame: Day 4
Serum indicators of insulin resistance (fasting glucose, insulin, lipids and serum retinol binding protein-4); adiponectins and inflammatory cytokines.
Time frame: Day 14 (Pioglitazone) and Day 4 (Prednisone)
ALT and AST
Time frame: Day 14 (Pioglitazone) and Day 4 (Prednisone)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Derived from this study: PubMed 22412837Chojkier M, Elkhayat H, Sabry D, Donohue M, Buck M. Pioglitazone decreases hepatitis C viral load in overweight, treatment naive, genotype 4 infected-patients: a pilot study. PLoS One. 2012;7(3):e31516. doi: 10.1371/journal.pone.0031516. Epub 2012 Mar 7.
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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.
Mario Chojkier, MD principal investigator
UCSD
Martina Buck, PhD principal investigator
UCSD
Hesham Elkhayat, MD principal investigator
Cairo University, Egypt
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pioglitazone and Prednisone in people with Hepatitis C, run by University of California, San Diego at 2 sites in 2 countries.
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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Egypt. 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 was withdrawn before enrolling participants, so there are no results.
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?
HCV RNA (time frame: 2 weeks). 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 NCT01157975, 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 2 Dec 2019.