Hepatitis CPhase 3NCT00038974
Hepatitis C Antiviral Resistance in African-Americans
A Phase 3 study testing peginterferon alfa-2a and Ribavirin in people with Hepatitis C, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 8 sites in United States.
Trial summary
This study is designed to test the hypothesis that African-Americans respond less well to combination pegylated interferon and ribavirin therapy than Caucasian-Americans who have chronic hepatitis C genotype 1 and who were not previously treated with either interferon or ribavirin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- peginterferon alfa-2a and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 8 sitesUnited States
- Study dates
- Aug 2002to Nov 2005
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years at screening
- Black/African American or White/Caucasian
- Born in the United States
- Quantifiable Serum HCV RNA
- Hepatitis C genotype 1
- Liver biopsy consistent with chronic hepatitis C
- Negative urine pregnancy test
- Males and Females must be using two reliable forms of effective contraception while on drug and during follow-up.
Who cannot join
- Previous treatment with interferon or ribavirin
- Positive test at screening for anti-HIV
- Positive test for HBsAg
- Alcohol consumption of more than two drinks/day
- History of other chronic liver disease
- Pregnant or breast-feeding women
Show all 24Show fewer
- Male partners of women who are pregnant or contemplating pregnancy
- Neutrophil count <1000 cells/mm3
- Hgb <11 g/dl in women or 12 g/dl in men
- Platelet count <75,000 cells/mm3.
- Thalassemia, spherocytosis, history of GI bleeding or those at increased risk of anemia
- Serum creatinine level >1.5 times the upper limit of normal at screening or CrCl < 75cc/min
- Current dialysis
- Alcohol or drug abuse within 6 months
- Current (<6 months)severe psychiatric disorder
- History of immunologically mediated disease
- Decompensated liver disease
- High risk cardiovascular/coronary artery disease
- Severe seizure disorder or anticonvulsant use
- Solid organ or bone marrow transplantation
- Thyroid disease poorly controlled on prescribed medications
- History or other evidence of retinopathy
- Chronic use of oral steroids
- Inability or unwillingness to provide informed consent or abide by the study protocol
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of North Carolina
Chapel Hill, North Carolina, 27599
Rush University
Chicago, Illinois, 60612
University of Miami School of Medicine
Miami, Florida, 33136
New York-Presbyterian Medical Center
New York, New York, 10032
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (Virahep-C)
This study is designed to test the hypothesis that African-Americans respond less well to combination pegylated interferon and ribavirin therapy than Caucasian-Americans who have chronic hepatitis C genotype 1 and who were not previously treated with either interferon or ribavirin. Reasons for differences in response, regardless of race, will be studied.
- Conditions
- Hepatitis C
- Being tested
- peginterferon alfa-2a, Ribavirin
- Keywords
- Hepatitis C, Interferon, Ribavirin, Efficacy, Viral load, Genetics, Cytokines, Immunology
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peginterferon alfa-2aDrug
RibavirinDrug
| Study group | Role | What they receive |
|---|---|---|
| Interferon and rivavirin | Experimental | All patients received peginterferon alfa-2a in a dose of 180 μg weekly and ribavirin in a dose of 1000 (for patients with a body weight of ⩽75 kg) or 1200 mg (for those with a body weight of >75 kg) daily. Receives: Drug: peginterferon alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response (SVR)
The primary end point of therapy was an SVR that was definied as the absences of detectable HCV RNA in serum 24 weeks after therapy was stopped.
Measured: 24 weeks after therapy is discontinued
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2002 (estimated)
- Study startAug 2002
- Primary completionDec 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Cancer Institute (NCI), National Center for Advancing Translational Sciences (NCATS), Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Patricia Robuck, Study director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038974
- Sponsor's protocol ID
- Virahep-C (completed)
- Other IDs
- U01DK060329, U01DK060340, U01DK060324, U01DK060344, U01DK060327, U01DK060335, U01DK060352, U01DK060342
- Status last verified
- Aug 2017
- First submitted
- 5 Jun 2002
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data are available in the NIDDK Central Repository
Publications
Conjeevaram HS, Fried MW, Jeffers LJ, Terrault NA, Wiley-Lucas TE, Afdhal N, Brown RS, Belle SH, Hoofnagle JH, Kleiner DE, Howell CD; Virahep-C Study Group. Peginterferon and ribavirin treatment in African American and Caucasian American patients with hepatitis C genotype 1. Gastroenterology. 2006 Aug;131(2):470-7. doi: 10.1053/j.gastro.2006.06.008.
PubMed 16890601Sarkar S, Jiang Z, Evon DM, Wahed AS, Hoofnagle JH. Fatigue before, during and after antiviral therapy of chronic hepatitis C: results from the Virahep-C study. J Hepatol. 2012 Nov;57(5):946-52. doi: 10.1016/j.jhep.2012.06.030. Epub 2012 Jul 1.
PubMed 22760009Dove LM, Rosen RC, Ramcharran D, Wahed AS, Belle SH, Brown RS, Hoofnagle JH; Virahep-C Study Group. Decline in male sexual desire, function, and satisfaction during and after antiviral therapy for chronic hepatitis C. Gastroenterology. 2009 Sep;137(3):873-84, 884.e1. doi: 10.1053/j.gastro.2009.05.060. Epub 2009 Jun 13.
PubMed 19527724Hoofnagle JH, Wahed AS, Brown RS Jr, Howell CD, Belle SH; Virahep-C Study Group. Early changes in hepatitis C virus (HCV) levels in response to peginterferon and ribavirin treatment in patients with chronic HCV genotype 1 infection. J Infect Dis. 2009 Apr 15;199(8):1112-20. doi: 10.1086/597384.
PubMed 19284286Cannon NA, Donlin MJ, Fan X, Aurora R, Tavis JE; Virahep-C Study Group. Hepatitis C virus diversity and evolution in the full open-reading frame during antiviral therapy. PLoS One. 2008 May 7;3(5):e2123. doi: 10.1371/journal.pone.0002123.
PubMed 18463735
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (Virahep-C)
- ClinicalTrials.gov ID
- NCT00038974
- Acronym / sponsor ID
- Virahep-C (completed)
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, Interferon, Ribavirin, Efficacy, Viral load, Genetics, Cytokines, Immunology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Cancer Institute (NCI), National Center for Advancing Translational Sciences (NCATS), Hoffmann-La Roche
- Study start
- Aug 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 10 Jun 2002 (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.
This study is designed to test the hypothesis that African-Americans respond less well to combination pegylated interferon and ribavirin therapy than Caucasian-Americans who have chronic hepatitis C genotype 1 and who were not previously treated with either interferon or ribavirin. Reasons for differences in response, regardless of race, will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interferon and rivavirin | Experimental | Drug: peginterferon alfa-2a, Drug: RibavirinAll patients received peginterferon alfa-2a in a dose of 180 μg weekly and ribavirin in a dose of 1000 (for patients with a body weight of ⩽75 kg) or 1200 mg (for those with a body weight of >75 kg) daily. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 70 years at screening
- Black/African American or White/Caucasian
- Born in the United States
- Quantifiable Serum HCV RNA
- Hepatitis C genotype 1
Key exclusion criteria (24 listed)
- Previous treatment with interferon or ribavirin
- Positive test at screening for anti-HIV
- Positive test for HBsAg
- Alcohol consumption of more than two drinks/day
- History of other chronic liver disease
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 |
|---|---|---|
| peginterferon alfa-2a | Drug | Interferon and rivavirin |
| Ribavirin | Drug | Interferon and rivavirin |
Primary outcome
Sustained Virologic Response (SVR)
Time frame: 24 weeks after therapy is discontinued
The primary end point of therapy was an SVR that was definied as the absences of detectable HCV RNA in serum 24 weeks after therapy was stopped.
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 3 Aug 2017.
- Results publication: PubMed 16890601Conjeevaram HS, Fried MW, Jeffers LJ, Terrault NA, Wiley-Lucas TE, Afdhal N, Brown RS, Belle SH, Hoofnagle JH, Kleiner DE, Howell CD; Virahep-C Study Group. Peginterferon and ribavirin treatment in African American and Caucasian American patients with hepatitis C genotype 1. Gastroenterology. 2006 Aug;131(2):470-7. doi: 10.1053/j.gastro.2006.06.008.
- Derived from this study: PubMed 22760009Sarkar S, Jiang Z, Evon DM, Wahed AS, Hoofnagle JH. Fatigue before, during and after antiviral therapy of chronic hepatitis C: results from the Virahep-C study. J Hepatol. 2012 Nov;57(5):946-52. doi: 10.1016/j.jhep.2012.06.030. Epub 2012 Jul 1.
- Derived from this study: PubMed 19527724Dove LM, Rosen RC, Ramcharran D, Wahed AS, Belle SH, Brown RS, Hoofnagle JH; Virahep-C Study Group. Decline in male sexual desire, function, and satisfaction during and after antiviral therapy for chronic hepatitis C. Gastroenterology. 2009 Sep;137(3):873-84, 884.e1. doi: 10.1053/j.gastro.2009.05.060. Epub 2009 Jun 13.
- Derived from this study: PubMed 19284286Hoofnagle JH, Wahed AS, Brown RS Jr, Howell CD, Belle SH; Virahep-C Study Group. Early changes in hepatitis C virus (HCV) levels in response to peginterferon and ribavirin treatment in patients with chronic HCV genotype 1 infection. J Infect Dis. 2009 Apr 15;199(8):1112-20. doi: 10.1086/597384.
- Derived from this study: PubMed 18463735Cannon NA, Donlin MJ, Fan X, Aurora R, Tavis JE; Virahep-C Study Group. Hepatitis C virus diversity and evolution in the full open-reading frame during antiviral therapy. PLoS One. 2008 May 7;3(5):e2123. doi: 10.1371/journal.pone.0002123.
- Individual participant dataSharing planned: Yes. Individual participant data are available in the NIDDK Central Repository
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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.
Patricia Robuck study director
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing peginterferon alfa-2a and Ribavirin in people with Hepatitis C, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 8 sites 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 8 inclusion and 24 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 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Sustained Virologic Response (SVR) (time frame: 24 weeks after therapy is discontinued). 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 NCT00038974, which also lists 5 linked publications.
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 3 Aug 2017.