Chronic Hepatitis CNCT00926016
Pioglitazone on Viral Kinetics, Cytokines and Innate Immunity in Insulin Resistant CHC GT 1 Subjects
A study testing Pioglitazone (Actos) in people with Chronic Hepatitis C, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if rosiglitazone, a medicine used to treat diabetes, improves response to anti-viral treatment. 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 (Actos)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Sep 2010
- Phase
- Interventional
- 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
- HCV-Ab or HCV-RNA by PCR Positive for at least six months (to rule out acute seroconversion)
- Serum positive for HCV-RNA by PCR assay
- Must have insulin resistance, defined as a QUICKI score < 0.35. QUICKI
- Liver biopsy consistent with CHC within 24 months prior to enrollment
- Compensated liver disease with the following minimum hematological, biochemical, and serologic criteria at the Screening Visit (WNL = within normal limits):
- Hemoglobin values of >12 gm/dL for females and >13 gm/dL for males.
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- WBC >3,000/ mm3
- Neutrophil count > 1,500/mm3
- Platelets >65,000/ mm3
- Direct bilirubin, within 20% of ULN
- Indirect bilirubin, within normal limits (WNL)
- Albumin >3gm/dL
- Serum creatinine < 20% above the ULN
- TSH WNL
- Alpha fetoprotein value < 100 ng/mL
Who cannot join
- Prior interferon based therapy
- Use of insulin
- Fasting glucose levels > 200 mg/dl
- Women who are pregnant or breast-feeding
- No other thiazolidinedione after liver biopsy and/or during the entire study (
- Hepatitis C of non-genotype 1
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- Suspected hypersensitivity to pioglitazone
- Any cause for liver disease other than chronic hepatitis C, insulin resistance, or NAFLD, including but not limited to:
- Hemochromatosis
- Alpha-1 antitrypsin deficiency
- Co-infection with HBV
- Wilson's disease
- Autoimmune hepatitis
- Significant alcohol use
- Drug-related liver disease
- Any condition that would prevent the subject from having a liver biopsy.
- Hemoglobinopathies that could potentially compromise patient safety
- Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, spontaneous encephalopathy.
- Participants with organ transplants other than cornea and hair transplant.
- Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as:
- Preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded
- Substance abuse, such as alcohol, IV drugs and inhaled drugs
- Alcohol consumption is to be strongly discouraged
- Seizure disorders not controlled with medication
- Significant cardiovascular dysfunction within the past 12 months
- Chronic pulmonary disease with documented pulmonary hypertension
- Immunologically mediated disease [e.g., inflammatory bowel disease (Crohn's disease, ulcerative colitis)], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosis, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis
- Any medical condition requiring, or likely to require, chronic systemic administration of steroids during the course of the study
- Evidence of an active or suspected cancer or a history of malignancy where the risk of reoccurrence is ≥ 20% within two years
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: Assessment of the Efficacy of Pioglitazone on Viral Kinetics, Cytokines, and Innate Immunity in a Group of Insulin Resistant, Treatment Naïve, Chronic Hepatitis C, Genotype 1 Patients
The purpose of this study is to determine if rosiglitazone, a medicine used to treat diabetes, improves response to anti-viral treatment.
Read the detailed description
The aim of the study will be to determine if an insulin sensitizing thiazolidinedione (TZD) improves (1) baseline viremia, (2) enhances viral kinetics, (3) improves cytokine profiles and (4) up regulates innate cellular immunity (presumably adaptive immunity is up regulated as well) as measured by the bioactivity of the collected biomarkers.
- Conditions
- Chronic Hepatitis C
- Being tested
- Pioglitazone (Actos)
- Keywords
- Hepatitis C
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone (Actos)Drug
pioglitazone 45 mg a day
| Study group | Role | What they receive |
|---|---|---|
| pioglitazone | Active comparator | Treatment with pioglitazone 45 mg a day for 3 months Receives: Drug: Pioglitazone (Actos) |
| No intervention | No intervention | Monitoring period without pioglitazone for 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in baseline viremia and viral kinetics, and/or pro-inflammatory cytokines decrease, and/or markers of innate immunity are upregulated to position a more favorable response to current CHC therapy.
Measured: 104 days
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 startJun 2006
- Primary completionMar 2010
- Study completionSep 2010
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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- The Geneva Foundation
- 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
- NCT00926016
- Sponsor's protocol ID
- C.2006.152
- Status last verified
- Feb 2012
- First submitted
- 22 Jun 2009
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
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
- Assessment of the Efficacy of Pioglitazone on Viral Kinetics, Cytokines, and Innate Immunity in a Group of Insulin Resistant, Treatment Naïve, Chronic Hepatitis C, Genotype 1 Patients
- ClinicalTrials.gov ID
- NCT00926016
- Acronym / sponsor ID
- C.2006.152
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- The Geneva Foundation
- Study start
- Jun 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Sep 2010 (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 purpose of this study is to determine if rosiglitazone, a medicine used to treat diabetes, improves response to anti-viral treatment.
Detailed description
The aim of the study will be to determine if an insulin sensitizing thiazolidinedione (TZD) improves (1) baseline viremia, (2) enhances viral kinetics, (3) improves cytokine profiles and (4) up regulates innate cellular immunity (presumably adaptive immunity is up regulated as well) as measured by the bioactivity of the collected biomarkers.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pioglitazone | Active comparator | Drug: Pioglitazone (Actos)Treatment with pioglitazone 45 mg a day for 3 months |
| No intervention | No intervention | –Monitoring period without pioglitazone for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- HCV-Ab or HCV-RNA by PCR Positive for at least six months (to rule out acute seroconversion)
- Serum positive for HCV-RNA by PCR assay
- Must have insulin resistance, defined as a QUICKI score < 0.35. QUICKI
- Liver biopsy consistent with CHC within 24 months prior to enrollment
- Compensated liver disease with the following minimum hematological, biochemical, and serologic criteria at the Screening Visit (WNL = within normal limits):
Key exclusion criteria (29 listed)
- Prior interferon based therapy
- Use of insulin
- Fasting glucose levels > 200 mg/dl
- Women who are pregnant or breast-feeding
- No other thiazolidinedione after liver biopsy and/or during the entire study (
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)pioglitazone 45 mg a day | Drug | pioglitazone |
Primary outcome
Improvement in baseline viremia and viral kinetics, and/or pro-inflammatory cytokines decrease, and/or markers of innate immunity are upregulated to position a more favorable response to current CHC therapy.
Time frame: 104 days
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.
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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.
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 study testing Pioglitazone (Actos) in people with Chronic 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 15 inclusion and 29 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.
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 in baseline viremia and viral kinetics, and/or pro-inflammatory cytokines decrease, and/or markers of innate immunity are upregulated to position a more favorable response to current CHC therapy. (time frame: 104 days). 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.