Hepatitis CPhase 4NCT00207363
Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With CHC
A Phase 4 study testing Ribavirin, Peg interferon alfa 2b and induction therapy in people with Hepatitis C, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to see which of two doses of PEG (polyethylene glycol) interferon alfa-2b in combination with Ribavirin for 48 weeks is more effective at elimination of hepatitis C. 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?
- Ribavirin, Peg interferon alfa 2b and induction therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2002to Jan 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
- willing to give written informed consent and be able to adhere to dose and visit schedules.
- 18years of age or older of either gender and any race. Subjects who are over 65 years of age must be in generally good health.
- Serum positive for HCV-RNA by PCR assay Treatment naïve Genotype 1 \& 4 HCV participants
- ALT either elevated or persistently normal
- Liver biopsy within 36 months with a pathology report confirming the histological diagnosis is consistent with CHC
- Compensated liver disease with the following minimum hematologic, biochemical, and serologic criteria at the Entry Visit
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- Hemoglobin values of <12 gm/dL for females \& <13 gm/dL for males.
- WBC <3,000/mm3
- Neutrophil count < 1,500/mm3
- Platelets <65,000/mm3
- Direct bilirubin, within 20% of (ULN)
- Indirect bilirubin, WNL (unless non-hepatitis related factors such as Gilbert's disease explain an indirect bilirubin rise
- Albumin, WNL
- Serum creatinine, within 20% of ULN
- Glucose should be less than 115 mg/dL
- Thyroid Stimulating Hormone (TSH), WNL
- HIV negative
- HBsAg negative
- Alpha fetoprotein value < 100 ng/mL obtained within one year prior to entry for patients with Stage 3 or 4 liver disease
- Reconfirmation \& documentation sexually active female subjects of childbearing potential are practicing adequate contraception during the treatment period \& 6 months following the last dose of study medication
- Reconfirmation that sexually active male subjects are practicing acceptable methods of contraception during the treatment period \& for 6 months following the last dose of study medication
Who cannot join
- Women who are pregnant or nursing.
- Hepatitis C of non-genotype 1 or 4
- Previous anti-viral therapy
- Suspected hypersensitivity to interferon, PEG-interferon, ribavirin
- Any other cause for the liver disease other than chronic hepatitis C including but not limited to:
- Co-infection with HBV
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- Hemochromatosis
- Alpha-1 antitrypsin deficiency
- Wilson's disease
- Autoimmune hepatitis
- Alcoholic liver disease
- Obesity-induced liver disease
- Drug-related liver disease
- Hemophilia or any other condition that would prevent the subject from having a liver biopsy, including anticoagulant therapy
- Hemoglobinopathies
- Evidence of advanced liver disease (ascites, bleeding varices,spontaneous encephalopathy)
- 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
- CNS trauma or active seizure disorders requiring medication
- Significant cardiovascular dysfunction within the past 12 months. Subjects with ECG showing clinically significant abnormalities
- Poorly controlled DM
- Chronic pulmonary disease (COPD)with documented pulmonary hypertension
- Immunologically mediated disease (e.g., inflammatory bowel disease, RA, idiopathic thrombocytopenia purpura, lupus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis)
- Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids
- Active gout
- Substance abuse
- not willing to be abstain from the consumption of alcohol.
- clinically significant retinal abnormalities
- Any other condition that in the opinion of the Investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol
- Known HIV Positive
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: Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With Chronic Hepatitis C
The purpose of this study is to see which of two doses of PEG (polyethylene glycol) interferon alfa-2b in combination with Ribavirin for 48 weeks is more effective at elimination of hepatitis C.
The primary objective of this study is to compare the efficacy of Induction PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) to standard PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) in patients with chronic hepatitis C.
Read the detailed description
The purpose of this study is to determine if the use of induction dose PEG-Intron in combination with Rebetol will enhance the elimination of Hepatitis C in treatment naïve patients with genotype 1 and 4.
Currently PEG-Interferon alfa-2b plus Ribavirin results in a sustained response in 54-61% of patients with Hepatitis C. Those with genotype 1and 4 and high viral loads are the most likely to have a less favorable response. The administration of induction dose interferon in combination with Ribavirin may yield an improved sustained response rate in these more difficult to treat patients with chronic Hepatitis C.
- Conditions
- Hepatitis C
- Being tested
- Ribavirin, Peg interferon alfa 2b, induction therapy
- Keywords
- Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ribavirin, Peg interferon alfa 2bDrug
Also called Peg interferon alfa 2b (Peg Intron)
Peg interferon alfa 2b 1.5mcg/kg/wk for 48 weeks ribavirin 13+/-2 mg/kg daily for 48 weeks
induction therapyDrug
Also called Peg Intron (peginterferon alfa 2b
Peg Intron 3.0mcg/kg/wk for 12 weeks then Peg interon 1.5mcg/kg/week for 36 weeks
| Study group | Role | What they receive |
|---|---|---|
| Initial induction therapy | Experimental | Receive Peg Intron 3.0mcg/kg/wk for 12 weeks followed by Peg Intron 1.5 mcg/kg/wk for 36 weeks Receives: Drug: induction therapy |
| Standard of Care | Active comparator | Peg Inter 1.5mcg/kg/wk for 48 weeks Receives: Drug: Ribavirin, Peg interferon alfa 2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to compare the efficacy of Induction PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) to standard PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) in patients with chronic hepatitis C.
Serum HCV-RNA will be evaluated at Weeks 0, 12, 24, and 48 during treatment and at Week 24 following the end of therapy. The primary efficacy endpoint is the loss of HCV-RNA at 6 months of follow up.
Measured: 72 weeks
Secondary outcomes (1)
The loss of HCV-RNA at 6 months of follow up. If the HCV-RNA has not decreased by one log at treatment week 24, the patient will be classified as a treatment nonresponder and medications are discontinued.
Serum HCV-RNA will be evaluated at Weeks 0, 12, 24, and 48 during treatment and at Week 24 following the end of therapy. The primary efficacy endpoint is the loss of HCV-RNA at 6 months of follow up.
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 startFeb 2002
- Primary completionJan 2010
- Study completionJan 2010
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- T.R.U.E. Research Foundation
- Responsible party
- Principal investigator, Stephen A Harrison, Brooke Army Medical Center
- Investigators
- Stephen Harrison, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207363
- Sponsor's protocol ID
- C2002.076
- Status last verified
- Feb 2012
- First submitted
- 14 Sep 2005
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Brady DE, Torres DM, An JW, Ward JA, Lawitz E, Harrison SA. Induction pegylated interferon alfa-2b in combination with ribavirin in patients with genotypes 1 and 4 chronic hepatitis C: a prospective, randomized, multicenter, open-label study. Clin Gastroenterol Hepatol. 2010 Jan;8(1):66-71.e1. doi: 10.1016/j.cgh.2009.08.036. Epub 2009 Sep 10.
PubMed 19747986
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
- Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00207363
- Acronym / sponsor ID
- C2002.076
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- T.R.U.E. Research Foundation
- Study start
- Feb 2002
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 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.
The purpose of this study is to see which of two doses of PEG (polyethylene glycol) interferon alfa-2b in combination with Ribavirin for 48 weeks is more effective at elimination of hepatitis C.
The primary objective of this study is to compare the efficacy of Induction PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) to standard PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) in patients with chronic hepatitis C.
Detailed description
The purpose of this study is to determine if the use of induction dose PEG-Intron in combination with Rebetol will enhance the elimination of Hepatitis C in treatment naïve patients with genotype 1 and 4.
Currently PEG-Interferon alfa-2b plus Ribavirin results in a sustained response in 54-61% of patients with Hepatitis C. Those with genotype 1and 4 and high viral loads are the most likely to have a less favorable response. The administration of induction dose interferon in combination with Ribavirin may yield an improved sustained response rate in these more difficult to treat patients 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 |
|---|---|---|
| Initial induction therapy | Experimental | Drug: induction therapyReceive Peg Intron 3.0mcg/kg/wk for 12 weeks followed by Peg Intron 1.5 mcg/kg/wk for 36 weeks |
| Standard of Care | Active comparator | Drug: Ribavirin, Peg interferon alfa 2bPeg Inter 1.5mcg/kg/wk for 48 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- willing to give written informed consent and be able to adhere to dose and visit schedules.
- 18years of age or older of either gender and any race. Subjects who are over 65 years of age must be in generally good health.
- Serum positive for HCV-RNA by PCR assay Treatment naïve Genotype 1 \& 4 HCV participants
- ALT either elevated or persistently normal
- Liver biopsy within 36 months with a pathology report confirming the histological diagnosis is consistent with CHC
Key exclusion criteria (30 listed)
- Women who are pregnant or nursing.
- Hepatitis C of non-genotype 1 or 4
- Previous anti-viral therapy
- Suspected hypersensitivity to interferon, PEG-interferon, ribavirin
- Any other cause for the liver disease other than chronic hepatitis C including but not limited to:
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 |
|---|---|---|
| Ribavirin, Peg interferon alfa 2bAlso: Peg interferon alfa 2b (Peg Intron)Peg interferon alfa 2b 1.5mcg/kg/wk for 48 weeks ribavirin 13+/-2 mg/kg daily for 48 weeks | Drug | Standard of Care |
| induction therapyAlso: Peg Intron (peginterferon alfa 2bPeg Intron 3.0mcg/kg/wk for 12 weeks then Peg interon 1.5mcg/kg/week for 36 weeks | Drug | Initial induction therapy |
Primary outcome
The primary objective of this study is to compare the efficacy of Induction PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) to standard PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) in patients with chronic hepatitis C.
Time frame: 72 weeks
Serum HCV-RNA will be evaluated at Weeks 0, 12, 24, and 48 during treatment and at Week 24 following the end of therapy. The primary efficacy endpoint is the loss of HCV-RNA at 6 months of follow up.
1 secondary outcome
The loss of HCV-RNA at 6 months of follow up. If the HCV-RNA has not decreased by one log at treatment week 24, the patient will be classified as a treatment nonresponder and medications are discontinued.
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.
- Background: PubMed 19747986Brady DE, Torres DM, An JW, Ward JA, Lawitz E, Harrison SA. Induction pegylated interferon alfa-2b in combination with ribavirin in patients with genotypes 1 and 4 chronic hepatitis C: a prospective, randomized, multicenter, open-label study. Clin Gastroenterol Hepatol. 2010 Jan;8(1):66-71.e1. doi: 10.1016/j.cgh.2009.08.036. Epub 2009 Sep 10.
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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 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 Ribavirin, Peg interferon alfa 2b and induction therapy 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 21 inclusion and 30 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?
The primary objective of this study is to compare the efficacy of Induction PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) to standard PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) in patients with chronic hepatitis C. (time frame: 72 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 NCT00207363, 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 14 Feb 2012.