Hepatitis cPhase 4NCT00926614
Efficacy of Actos Lipitor Pegasys & Ribavirin in CHC GT 1 Patients Who Relapsed or Nonresponded to Peg/Riba
A Phase 4 study testing pioglitazone (Actos) and atorvastatin (Lipitor) in people with Hepatitis c, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
The aim of the study will be to determine if an insulin sensitizing thiazolidinedione plus a lipid lowering agent (statin) improves sustained virologic response rates in patients who have previously not responded or relapsed on standard pegylated interferon and ribavirin therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis c
- What is being tested?
- pioglitazone (Actos) and atorvastatin (Lipitor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2011
- Phase
- Phase 4
- 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
- GT 1 previously treated with pegylated interferon \& ribavirin \& either non-responded or relapsed after cessation of therapy
- Insulin resistance
- Compensated liver disease
- WBC < 3,000/ mm3
- Neutrophil count < 1,500/mm3
- Platelets < 65,000/ mm3
- Albumin > 3 gm/dL
Who cannot join
- Participants on metformin or other thiazolidinedione must have 3month wash-out period
- Women who are pregnant or breast-feeding
- Males with pregnant partners
- Co-infection with HAV, HBV, or HIV
- Ophthalmic abnormalities such as severe retinopathy
- Poorly controlled thyroid dysfunction
Show all 12Show fewer
- Serum creatinine concentration > 1.5 times ULN
- Severe psychiatric or neuropsychiatric disorders
- History of alcoholism or drug addiction 1 year prior to screening
- Seizure disorders not controlled with medication
- Significant cardiovascular dysfunction within the past 12 months
- Chronic pulmonary disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
San Antonio, Texas, 78234
About this study
Official title: 48 Week Pilot Trial Assessing the Efficacy of Pioglitazone, Atorvastatin, Pegasys and Weight Based Ribavirin in Chronic Hepatitis C, Genotype 1 Patients Who Have Previously Relapsed or Did Not Respond to PegInterferon /Ribavirin Therapy
The aim of the study will be to determine if an insulin sensitizing thiazolidinedione plus a lipid lowering agent (statin) improves sustained virologic response rates in patients who have previously not responded or relapsed on standard pegylated interferon and ribavirin therapy.
Read the detailed description
The study will evaluate the use of atorvastatin and pioglitazone in the pre-treatment of insulin resistance and lipid levels prior to the addition of pegylated interferon and ribavirin for chronic hepatitis C (CHC). If improvement is seen in insulin resistance patients may then be in a position to respond more favorably to current antiviral therapy consisting of pegylated interferon and ribavirin.
This study could demonstrate the value of pretreating and continuing treatment for insulin resistance with pioglitazone in CHC, genotype 1 patients who have previously not responded or relapsed to prior pegylated interferon and ribavirin treatment. Changes in lipids are not a primary or secondary endpoint in this study.
- Conditions
- Hepatitis c
- Being tested
- pioglitazone (Actos), atorvastatin (Lipitor)
- Keywords
- GT1, HCV, non responder, relapser
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazone (Actos)Drug
Also called Actos
pioglitazone 30 mg qd for 30 days, then increase to 45 mg
atorvastatin (Lipitor)Drug
Also called Lipitor
atorvastatin 40 mg for 30 days then increase to 80 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Pioglitizone and Atorvastatin | Experimental | Pioglitazone and Atorvastatin added to standard of care Pegasys and weight based ribavirin Receives: Drug: pioglitazone (Actos); Drug: atorvastatin (Lipitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement is seen in insulin resistance patients to be in a position to respond more favorably to current antiviral therapy consisting of pegylated interferon and ribavirin.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startSep 2008
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Stephen A Harrison, Brooke Army Medical Center
- Investigators
- Stephen A Harrison, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926614
- Sponsor's protocol ID
- C.2008.153
- Status last verified
- Feb 2012
- First submitted
- 22 Jun 2009
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 48 Week Pilot Trial Assessing the Efficacy of Pioglitazone, Atorvastatin, Pegasys and Weight Based Ribavirin in Chronic Hepatitis C, Genotype 1 Patients Who Have Previously Relapsed or Did Not Respond to PegInterferon /Ribavirin Therapy
- ClinicalTrials.gov ID
- NCT00926614
- Acronym / sponsor ID
- C.2008.153
- Conditions
- Hepatitis c
- Keywords
- GT1, HCV, non responder, relapser
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Sep 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 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 aim of the study will be to determine if an insulin sensitizing thiazolidinedione plus a lipid lowering agent (statin) improves sustained virologic response rates in patients who have previously not responded or relapsed on standard pegylated interferon and ribavirin therapy.
Detailed description
The study will evaluate the use of atorvastatin and pioglitazone in the pre-treatment of insulin resistance and lipid levels prior to the addition of pegylated interferon and ribavirin for chronic hepatitis C (CHC). If improvement is seen in insulin resistance patients may then be in a position to respond more favorably to current antiviral therapy consisting of pegylated interferon and ribavirin.
This study could demonstrate the value of pretreating and continuing treatment for insulin resistance with pioglitazone in CHC, genotype 1 patients who have previously not responded or relapsed to prior pegylated interferon and ribavirin treatment. Changes in lipids are not a primary or secondary endpoint in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pioglitizone and Atorvastatin | Experimental | Drug: pioglitazone (Actos), Drug: atorvastatin (Lipitor)Pioglitazone and Atorvastatin added to standard of care Pegasys and weight based ribavirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- GT 1 previously treated with pegylated interferon \& ribavirin \& either non-responded or relapsed after cessation of therapy
- Insulin resistance
- Compensated liver disease
Key exclusion criteria (12 listed)
- Participants on metformin or other thiazolidinedione must have 3month wash-out period
- Women who are pregnant or breast-feeding
- Males with pregnant partners
- Co-infection with HAV, HBV, or HIV
- Ophthalmic abnormalities such as severe retinopathy
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 |
|---|---|---|
| pioglitazone (Actos)Also: Actospioglitazone 30 mg qd for 30 days, then increase to 45 mg | Drug | Pioglitizone and Atorvastatin |
| atorvastatin (Lipitor)Also: Lipitoratorvastatin 40 mg for 30 days then increase to 80 mg daily | Drug | Pioglitizone and Atorvastatin |
Primary outcome
Improvement is seen in insulin resistance patients to be in a position to respond more favorably to current antiviral therapy consisting of pegylated interferon and ribavirin.
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
Related trials for Hepatitis c
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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.
Stephen A Harrison, MD principal investigator
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pioglitazone (Actos) and atorvastatin (Lipitor) in people with Hepatitis c, run by Brooke Army Medical Center at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 14 Feb 2012. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Improvement is seen in insulin resistance patients to be in a position to respond more favorably to current antiviral therapy consisting of pegylated interferon and ribavirin. (time frame: 36 weeks). 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 14 Feb 2012.