Hepatitis CPhase 4NCT00207402
Infergen, Ribavirin & Avandia in Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin
A Phase 4 study testing rosiglitazone in people with Hepatitis C, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
Genotype 1 hepatitis C virus (HCV) patients who did not respond (did not lose virus during treatment) or relapsed (virus went away on treatment but came back after treatment was stopped) after treatment with at least twelve weeks of a pegylated (long-acting) interferon and ribavirin will be considered for this study. 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?
- rosiglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jul 2010
- 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
- Participants willing to give written informed consent and able to adhere to dose and visit schedules.
- Adult participants 18 years of age or older of either gender or any race. Participants who are over 65 years of age must be in generally good health.
- HCV-antibody (Ab) or HCV-RNA positive by polymerase chain reaction (PCR) for at least 6 months.
- Serum positive for HCV-RNA by PCR assay.
- Subjects must be previous nonresponders or relapsers on pegylated interferon and ribavirin therapy.
- Liver biopsy within 24 months prior to enrollment into the protocol.
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- 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.
- White blood cells (WBC) < 3,000/mm3
- Neutrophil count < 1,500/mm3
- Platelets < 65,000/mm3
- Direct bilirubin, within 20% of upper limits of normal (ULN)
- Indirect bilirubin, (WNL) (unless non-hepatitis related factors such as Gilbert's disease explain an indirect bilirubin rise. In such cases indirect bilirubin must be < 3.0 mg/dL [< 51.3 µmol/L]).
- Albumin > 3 gm/dL
- Serum creatinine < 20% of ULN
- Thyroid stimulating hormone (TSH) WNL
- Alpha fetoprotein value < 100 ng/mL.
- Reconfirmation and documentation that sexually active female subjects of childbearing potential are practicing adequate contraception during the treatment period and for 6 months following the last dose of study medication. Female subjects must not be breast-feeding.
- Reconfirmation that sexually active male subjects are practicing two acceptable methods of contraception during the treatment period and for 6 months following the last dose of study medication.
Who cannot join
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- Participants on insulin are excluded.
- Participants on metformin or another thiazolidinedione must have a three-month wash-out period to be considered for the study.
- Women who are pregnant or breast-feeding
- Males whose female partner is pregnant
- No other thiazolidinedione after liver biopsy and/or during the entire study (other than those subjects randomized to receive rosiglitazone during the study)
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- Hepatitis C of non-genotype 1
- Suspected hypersensitivity to interferon, ribavirin, or rosiglitazone
- Any cause for liver disease other than chronic hepatitis C, insulin resistance, or non-alcoholic fatty liver disease (NAFLD), including but not limited to:
- Hemochromatosis
- Alpha-1 antitrypsin deficiency
- Co-infection with hepatitis B virus (HBV) [serum hepatitis B surface antigen (HBsAg) positive]
- Wilson's disease
- Autoimmune hepatitis
- Alcoholic liver disease (consumption of greater than 2 drinks a day on average)
- Drug-related liver disease
- Any condition that would prevent the subject from having a liver biopsy.
- Hemoglobinopathies that could potentially compromise patient safety (e.g., beta thalassemia major, sickle cell disease)
- Evidence of advanced liver disease
- 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.
- Participants with a history of mild depression may be considered for entry into the protocol provided that a pretreatment assessment of the subject's mental status supports that the participant is clinically stable.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
Official title: A Pilot Trial of Combination Therapy With Interferon Alfacon1, Ribavirin, & Rosiglitazone in a Group of Insulin Resistant, Chronic Hepatitis C, GT 1 Patients Who Are Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin
Genotype 1 hepatitis C virus (HCV) patients who did not respond (did not lose virus during treatment) or relapsed (virus went away on treatment but came back after treatment was stopped) after treatment with at least twelve weeks of a pegylated (long-acting) interferon and ribavirin will be considered for this study. There are two purposes to this study: first, to determine how rosiglitazone, a medicine used to treat diabetes, affects the HCV viral load; and second, to determine if treatment of insulin resistance with rosiglitazone prior to therapy for HCV will improve sustained virologic response (loss of virus that continues beyond six months after completion of HCV therapy) to HCV therapy.
Read the detailed description
This study will demonstrate the efficacy of treating insulin resistance with rosiglitazone in CHC, genotype 1 patients who have failed previous treatment with pegylated interferon and ribavirin. Pre-treatment with rosiglitazone may become the new standard of care prior to HCV therapy for those patients who are insulin resistant, increasing their chance for achieving an SVR on interferon alfacon-1 combination therapy and decreasing the morbidity and mortality associated with chronic hepatitis C.
- Conditions
- Hepatitis C
- Being tested
- rosiglitazone
- Keywords
- Hepatitis C, Insulin resistance
- Medical subject headings
- Hepatitis C, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosiglitazoneDrug
Also called Infergen (interferon alfacon-1), Avandia (rosiglitazone), Ribavirin
Infergen 15mcg/ d Avandia qd Ribavirin bid
| Study group | Role | What they receive |
|---|---|---|
| rosiglitazone | Active comparator | Treatment with rosiglitazone 4 mg twice a day for 3 months prior to and during the course of 48 weeks of treatment with interferon alfacon-1 15mcg/0.5ml SQ daily and weight-based ribavirin. Receives: Drug: rosiglitazone |
| No Avandia | No intervention | Monitoring period without rosiglitazone for 3 months prior to 48 weeks of interferon alfacon-1 15mcg/0.5ml SQ daily and weight-based ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
There is change in viral kinetics with improvement of insulin sensitivity
Measured: 104 days
Secondary outcomes (1)
There is significant improvement in the SVR obtained when treating insulin resistant patients with the insulin sensitizing medication, Avandia, prior to and during treatment with Infergen and ribavirin when compared to Infergen
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionJan 2010
- Study completionJul 2010
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- InterMune
- Responsible party
- Principal investigator, Stephen A Harrison, Brooke Army Medical Center
- Investigators
- Stephen A Harrison, MD, Principal investigator, Brooke Army Medical CenterShane Mills, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207402
- Sponsor's protocol ID
- C2005.143
- Status last verified
- Feb 2012
- First submitted
- 13 Sep 2005
- 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
- A Pilot Trial of Combination Therapy With Interferon Alfacon1, Ribavirin, & Rosiglitazone in a Group of Insulin Resistant, Chronic Hepatitis C, GT 1 Patients Who Are Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin
- ClinicalTrials.gov ID
- NCT00207402
- Acronym / sponsor ID
- C2005.143
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, Insulin resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- InterMune
- Study start
- Oct 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 21 Sep 2005 (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.
Genotype 1 hepatitis C virus (HCV) patients who did not respond (did not lose virus during treatment) or relapsed (virus went away on treatment but came back after treatment was stopped) after treatment with at least twelve weeks of a pegylated (long-acting) interferon and ribavirin will be considered for this study. There are two purposes to this study: first, to determine how rosiglitazone, a medicine used to treat diabetes, affects the HCV viral load; and second, to determine if treatment of insulin resistance with rosiglitazone prior to therapy for HCV will improve sustained virologic response (loss of virus that continues beyond six months after completion of HCV therapy) to HCV therapy.
Detailed description
This study will demonstrate the efficacy of treating insulin resistance with rosiglitazone in CHC, genotype 1 patients who have failed previous treatment with pegylated interferon and ribavirin. Pre-treatment with rosiglitazone may become the new standard of care prior to HCV therapy for those patients who are insulin resistant, increasing their chance for achieving an SVR on interferon alfacon-1 combination therapy and decreasing the morbidity and mortality associated with chronic hepatitis C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rosiglitazone | Active comparator | Drug: rosiglitazoneTreatment with rosiglitazone 4 mg twice a day for 3 months prior to and during the course of 48 weeks of treatment with interferon alfacon-1 15mcg/0.5ml SQ daily and weight-based ribavirin. |
| No Avandia | No intervention | –Monitoring period without rosiglitazone for 3 months prior to 48 weeks of interferon alfacon-1 15mcg/0.5ml SQ daily 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 (19 listed)
- Participants willing to give written informed consent and able to adhere to dose and visit schedules.
- Adult participants 18 years of age or older of either gender or any race. Participants who are over 65 years of age must be in generally good health.
- HCV-antibody (Ab) or HCV-RNA positive by polymerase chain reaction (PCR) for at least 6 months.
- Serum positive for HCV-RNA by PCR assay.
- Subjects must be previous nonresponders or relapsers on pegylated interferon and ribavirin therapy.
Key exclusion criteria (23 listed)
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- Participants on insulin are excluded.
- Participants on metformin or another thiazolidinedione must have a three-month wash-out period to be considered for the study.
- Women who are pregnant or breast-feeding
- Males whose female partner is pregnant
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 |
|---|---|---|
| rosiglitazoneAlso: Infergen (interferon alfacon-1), Avandia (rosiglitazone), RibavirinInfergen 15mcg/ d Avandia qd Ribavirin bid | Drug | rosiglitazone |
Primary outcome
There is change in viral kinetics with improvement of insulin sensitivity
Time frame: 104 days
1 secondary outcome
There is significant improvement in the SVR obtained when treating insulin resistant patients with the insulin sensitizing medication, Avandia, prior to and during treatment with Infergen and ribavirin when compared to Infergen
Time frame: 72 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.
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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
Shane Mills, 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 rosiglitazone 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 19 inclusion and 23 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?
There is change in viral kinetics with improvement of insulin sensitivity (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.