Chronic Hepatitis CPhase 3NCT00100659
PEDS-C: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C
A Phase 3 study testing Pegylated Interferon/ribavirin in people with Chronic Hepatitis C, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 11 sites in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of peginterferon alfa-2a (PEG-2a) in combination with ribavirin (RV) and PEG-2a alone for the treatment of chronic hepatitis C virus (CHC) infection in children. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Pegylated Interferon/ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2004to Feb 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female patients who are 5-18 years of age at enrollment (not yet reached 18th birthday at screening).
- HCV viremia (by any test) present on 2 tests separated by at least 6 months.
- Chronic liver disease, as indicated by inflammation and/or fibrosis, consistent with chronic hepatitis C infection on a liver biopsy obtained within the past 24 months, as assessed by a qualified pathologist, not consistent with other known liver disease and not normal.
- Compensated liver disease (Child-Pugh Grade A clinical classification)
- Signed informed consent from parent/legal guardian and willingness of parent/legal guardian to abide by the requirements of the study.
- Hemoglobin values >11 g/dL for females; > 12 g/dL for males
- Normal thyroid stimulating hormone (TSH)
- Able to swallow a ribavirin/placebo tablet
Who cannot join
- Any prior treatment with Interferon or ribavirin (RV)
- Receipt of any investigational drug <6 weeks prior to the first dose of study drug
- Any systemic antiviral therapy <6 weeks prior to the first dose of study drug. Exception: patients who have taken or are expected to require acyclovir for herpetic lesions
- Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
- History or other evidence of a medical condition associated with chronic liver disease other than HCV (abnormal ceruloplasmin, alpha-1-antitrypsin, ANA>1:160, SMA>1:80, anti-LKM antibody > 60 units))
- History or other evidence of bleeding from esophageal varices
Show all 27Show fewer
- Decompensated liver disease (e.g. conjugated bilirubin >1.5mg/dl, ascites, varices, Child-Pugh Grade B or C clinical classification)
- History of autoimmune or immunologically mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical evidence of rheumatoid arthritis)
- Absolute neutrophil count <1500 cells/mm3 , hemoglobin <11 g/dL for females and <12 g/dL for males, white blood count>17.5 x 109/L, or platelet count <90,000/ mm3
- Serum creatinine level >1.5 times the upper limit of normal for age
- Major depression according to the American Psychiatric Association, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicide attempt
- History or other evidence of chronic pulmonary or cardiac disease associated with functional limitation
- History of thyroid disease poorly controlled on prescribed medications. Patients with elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded
- Poorly controlled diabetes as defined by glycosylated hemoglobin of > 8%
- History of solid organ or bone marrow transplantation
- Evidence of severe retinopathy
- Coagulopathy (international normalized ratio>1.5)
- Evidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is >20% within 2 years.
- Hemoglobinopathy
- Hemophilia
- Severe retinopathy
- History of other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- Sexually active females of child-bearing potential (defined as age 10 years and older) and sexually active men who are not practicing two forms of effective contraception during treatment and during the 6 months after treatment has been concluded
- Females who have a positive serum pregnancy test within 7 days of initiation of treatment or who are breast-feeding
- Males whose female partners are pregnant
- Active substance abuse
- A sibling and/or any other child living in the same household or sharing the same primary caregiver enrolled in the study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Children's Hospital Boston
Boston, Massachusetts, 02115
Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
The Children's Hospital
Denver, Colorado, 80218
University of Florida
Gainesville, Florida, 32610
Indiana University School of Medicine, James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, 46202-5225
Columbia University Medical Center
New York, New York, 10032
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California, San Francisco
San Francisco, California, 94143-0136
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C
The purpose of this study is to determine the safety and efficacy of peginterferon alfa-2a (PEG-2a) in combination with ribavirin (RV) and PEG-2a alone for the treatment of chronic hepatitis C virus (CHC) infection in children.
The purpose of this study is also to determine whether PEG-2a in combination with RV or PEG-2a alone will result in a longer response rate in children with CHC.
- Conditions
- Chronic Hepatitis C
- Being tested
- Pegylated Interferon/ribavirin
- Keywords
- pediatric, hepatitis, children, HCV, PEG, PEG-2a, peginterferon alfa-2a, Pegylated Interferon, RV, ribavirin, Pegasys, CHC, chronic hepatitis C, chronic hepatitis C virus, hepatitis c, pediatric hepatitis, pediatric HCV
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Interferon/ribavirinDrug
| Study group | Role | What they receive |
|---|---|---|
| Pegylated interferon/ribavirin | Active comparator | Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.
Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets. Receives: Drug: Pegylated Interferon/ribavirin |
| Pegylated interferon/placebo | Placebo comparator | Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily). Receives: Drug: Pegylated Interferon/ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Viral Response (SVR)
SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma
Measured: at least 24 weeks after stopping treatment.
Secondary outcomes (1)
Adverse Events
Influenza-like, headache, and gastrointestinal symptoms
Measured: At any time up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2005 (estimated)
- Study startDec 2004
- Primary completionAug 2008
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Kathleen B Schwarz, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100659
- Sponsor's protocol ID
- 67767 (completed)
- Other IDs
- U01DK067767
- Status last verified
- Aug 2018
- First submitted
- 4 Jan 2005
- Last updated
- 24 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Protocols, manuals, and data will be posted at the NIDDK Central Repository
Publications
Murray KF, Rodrigue JR, Gonzalez-Peralta RP, Shepherd J, Barton BA, Robuck PR, Schwarz KB; PEDS-C Clinical Research Network. Design of the PEDS-C trial: pegylated interferon +/- ribavirin for children with chronic hepatitis C viral infection. Clin Trials. 2007;4(6):661-73. doi: 10.1177/1740774507085445.
PubMed 18042575Rodrigue JR, Balistreri W, Haber B, Jonas MM, Mohan P, Molleston JP, Murray KF, Narkewicz MR, Rosenthal P, Smith LJ, Lobritto SJ, Schwarz KB, Robuck PR, Barton B, Gonzalez-Peralta RP. Peginterferon with or without ribavirin has minimal effect on quality of life, behavioral/emotional, and cognitive outcomes in children. Hepatology. 2011 May;53(5):1468-75. doi: 10.1002/hep.24248.
PubMed 21351116Schwarz KB, Gonzalez-Peralta RP, Murray KF, Molleston JP, Haber BA, Jonas MM, Rosenthal P, Mohan P, Balistreri WF, Narkewicz MR, Smith L, Lobritto SJ, Rossi S, Valsamakis A, Goodman Z, Robuck PR, Barton BA; Peds-C Clinical Research Network. The combination of ribavirin and peginterferon is superior to peginterferon and placebo for children and adolescents with chronic hepatitis C. Gastroenterology. 2011 Feb;140(2):450-458.e1. doi: 10.1053/j.gastro.2010.10.047. Epub 2010 Oct 28.
PubMed 21036173Goodman ZD, Makhlouf HR, Liu L, Balistreri W, Gonzalez-Peralta RP, Haber B, Jonas MM, Mohan P, Molleston JP, Murray KF, Narkewicz MR, Rosenthal P, Smith LJ, Robuck PR, Schwarz KB. Pathology of chronic hepatitis C in children: liver biopsy findings in the Peds-C Trial. Hepatology. 2008 Mar;47(3):836-43. doi: 10.1002/hep.22094.
PubMed 18167062Narkewicz MR, Rosenthal P, Schwarz KB, Drack A, Margolis T, Repka MX; PEDS-C Study Group. Ophthalmologic complications in children with chronic hepatitis C treated with pegylated interferon. J Pediatr Gastroenterol Nutr. 2010 Aug;51(2):183-6. doi: 10.1097/MPG.0b013e3181b99cf0.
PubMed 20512062Delgado-Borrego A, Gonzalez-Peralta RP, Raza R, Negre B, Goodman ZD, Jonas MM, Chung RT, Ludwig DA; PEDS-C Clinical Research Network. Correlates of adiponectin in hepatitis C-infected children: the importance of body mass index. J Pediatr Gastroenterol Nutr. 2015 Feb;60(2):165-70. doi: 10.1097/MPG.0000000000000604.
PubMed 25313851Schwarz KB, Molleston JP, Jonas MM, Wen J, Murray KF, Rosenthal P, Gonzalez-Peralta RP, Lobritto SJ, Mogul D, Pavlovic V, Warne C, Wat C, Thompson B. Durability of Response in Children Treated With Pegylated Interferon alfa [corrected] 2a +/- Ribavirin for Chronic Hepatitis C. J Pediatr Gastroenterol Nutr. 2016 Jan;62(1):93-6. doi: 10.1097/MPG.0000000000000929.
PubMed 26284539Molleston JP, Mellman W, Narkewicz MR, Balistreri WF, Gonzalez-Peralta RP, Jonas MM, Lobritto SJ, Mohan P, Murray KF, Njoku D, Rosenthal P, Barton BA, Talor MV, Cheng I, Schwarz KB, Haber BA; PEDS-C Clinical Research Network. Autoantibodies and autoimmune disease during treatment of children with chronic hepatitis C. J Pediatr Gastroenterol Nutr. 2013 Mar;56(3):304-10. doi: 10.1097/MPG.0b013e3182774cae.
PubMed 23439301Jonas MM, Balistreri W, Gonzalez-Peralta RP, Haber B, Lobritto S, Mohan P, Molleston JP, Murray KF, Narkewicz MR, Rosenthal P, Schwarz KB, Barton BA, Shepherd JA, Mitchell PD, Duggan C. Pegylated interferon for chronic hepatitis C in children affects growth and body composition: results from the pediatric study of hepatitis C (PEDS-C) trial. Hepatology. 2012 Aug;56(2):523-31. doi: 10.1002/hep.25690. Epub 2012 Jul 6.
PubMed 22383118
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pegylated Interferon +/- Ribavirin for Children With Hepatitis C
- ClinicalTrials.gov ID
- NCT00100659
- Acronym / sponsor ID
- 67767 (completed)
- Conditions
- Chronic Hepatitis C
- Keywords
- pediatric, hepatitis, children, HCV, PEG, PEG-2a, peginterferon alfa-2a, Pegylated Interferon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Roche Pharma AG
- Study start
- Dec 2004
- Primary completion
- Aug 2008 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 5 Jan 2005 (estimated)
- Results
- Posted 1 Jul 2013
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 the safety and efficacy of peginterferon alfa-2a (PEG-2a) in combination with ribavirin (RV) and PEG-2a alone for the treatment of chronic hepatitis C virus (CHC) infection in children.
The purpose of this study is also to determine whether PEG-2a in combination with RV or PEG-2a alone will result in a longer response rate in children with CHC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pegylated interferon/ribavirin | Active comparator | Drug: Pegylated Interferon/ribavirinPegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly. Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets. |
| Pegylated interferon/placebo | Placebo comparator | Drug: Pegylated Interferon/ribavirinPlacebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily). |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Male or female patients who are 5-18 years of age at enrollment (not yet reached 18th birthday at screening).
- HCV viremia (by any test) present on 2 tests separated by at least 6 months.
- Chronic liver disease, as indicated by inflammation and/or fibrosis, consistent with chronic hepatitis C infection on a liver biopsy obtained within the past 24 months, as assessed by a qualified pathologist, not consistent with other known liver disease and not normal.
- Compensated liver disease (Child-Pugh Grade A clinical classification)
- Signed informed consent from parent/legal guardian and willingness of parent/legal guardian to abide by the requirements of the study.
Key exclusion criteria (27 listed)
- Any prior treatment with Interferon or ribavirin (RV)
- Receipt of any investigational drug <6 weeks prior to the first dose of study drug
- Any systemic antiviral therapy <6 weeks prior to the first dose of study drug. Exception: patients who have taken or are expected to require acyclovir for herpetic lesions
- Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
- History or other evidence of a medical condition associated with chronic liver disease other than HCV (abnormal ceruloplasmin, alpha-1-antitrypsin, ANA>1:160, SMA>1:80, anti-LKM antibody > 60 units))
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 |
|---|---|---|
| Pegylated Interferon/ribavirin | Drug | Pegylated interferon/placebo, Pegylated interferon/ribavirin |
Primary outcome
Sustained Viral Response (SVR)
Time frame: at least 24 weeks after stopping treatment.
SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma
1 secondary outcome
Adverse Events
Time frame: At any time up to 72 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18042575Murray KF, Rodrigue JR, Gonzalez-Peralta RP, Shepherd J, Barton BA, Robuck PR, Schwarz KB; PEDS-C Clinical Research Network. Design of the PEDS-C trial: pegylated interferon +/- ribavirin for children with chronic hepatitis C viral infection. Clin Trials. 2007;4(6):661-73. doi: 10.1177/1740774507085445.
- Results publication: PubMed 21351116Rodrigue JR, Balistreri W, Haber B, Jonas MM, Mohan P, Molleston JP, Murray KF, Narkewicz MR, Rosenthal P, Smith LJ, Lobritto SJ, Schwarz KB, Robuck PR, Barton B, Gonzalez-Peralta RP. Peginterferon with or without ribavirin has minimal effect on quality of life, behavioral/emotional, and cognitive outcomes in children. Hepatology. 2011 May;53(5):1468-75. doi: 10.1002/hep.24248.
- Results publication: PubMed 21036173Schwarz KB, Gonzalez-Peralta RP, Murray KF, Molleston JP, Haber BA, Jonas MM, Rosenthal P, Mohan P, Balistreri WF, Narkewicz MR, Smith L, Lobritto SJ, Rossi S, Valsamakis A, Goodman Z, Robuck PR, Barton BA; Peds-C Clinical Research Network. The combination of ribavirin and peginterferon is superior to peginterferon and placebo for children and adolescents with chronic hepatitis C. Gastroenterology. 2011 Feb;140(2):450-458.e1. doi: 10.1053/j.gastro.2010.10.047. Epub 2010 Oct 28.
- Results publication: PubMed 18167062Goodman ZD, Makhlouf HR, Liu L, Balistreri W, Gonzalez-Peralta RP, Haber B, Jonas MM, Mohan P, Molleston JP, Murray KF, Narkewicz MR, Rosenthal P, Smith LJ, Robuck PR, Schwarz KB. Pathology of chronic hepatitis C in children: liver biopsy findings in the Peds-C Trial. Hepatology. 2008 Mar;47(3):836-43. doi: 10.1002/hep.22094.
- Results publication: PubMed 20512062Narkewicz MR, Rosenthal P, Schwarz KB, Drack A, Margolis T, Repka MX; PEDS-C Study Group. Ophthalmologic complications in children with chronic hepatitis C treated with pegylated interferon. J Pediatr Gastroenterol Nutr. 2010 Aug;51(2):183-6. doi: 10.1097/MPG.0b013e3181b99cf0.
- Results publication: PubMed 25313851Delgado-Borrego A, Gonzalez-Peralta RP, Raza R, Negre B, Goodman ZD, Jonas MM, Chung RT, Ludwig DA; PEDS-C Clinical Research Network. Correlates of adiponectin in hepatitis C-infected children: the importance of body mass index. J Pediatr Gastroenterol Nutr. 2015 Feb;60(2):165-70. doi: 10.1097/MPG.0000000000000604.
- Results publication: PubMed 26284539Schwarz KB, Molleston JP, Jonas MM, Wen J, Murray KF, Rosenthal P, Gonzalez-Peralta RP, Lobritto SJ, Mogul D, Pavlovic V, Warne C, Wat C, Thompson B. Durability of Response in Children Treated With Pegylated Interferon alfa [corrected] 2a +/- Ribavirin for Chronic Hepatitis C. J Pediatr Gastroenterol Nutr. 2016 Jan;62(1):93-6. doi: 10.1097/MPG.0000000000000929.
- Derived from this study: PubMed 23439301Molleston JP, Mellman W, Narkewicz MR, Balistreri WF, Gonzalez-Peralta RP, Jonas MM, Lobritto SJ, Mohan P, Murray KF, Njoku D, Rosenthal P, Barton BA, Talor MV, Cheng I, Schwarz KB, Haber BA; PEDS-C Clinical Research Network. Autoantibodies and autoimmune disease during treatment of children with chronic hepatitis C. J Pediatr Gastroenterol Nutr. 2013 Mar;56(3):304-10. doi: 10.1097/MPG.0b013e3182774cae.
- Derived from this study: PubMed 22383118Jonas MM, Balistreri W, Gonzalez-Peralta RP, Haber B, Lobritto S, Mohan P, Molleston JP, Murray KF, Narkewicz MR, Rosenthal P, Schwarz KB, Barton BA, Shepherd JA, Mitchell PD, Duggan C. Pegylated interferon for chronic hepatitis C in children affects growth and body composition: results from the pediatric study of hepatitis C (PEDS-C) trial. Hepatology. 2012 Aug;56(2):523-31. doi: 10.1002/hep.25690. Epub 2012 Jul 6.
- Individual participant dataSharing planned: Yes. Protocols, manuals, and data will be posted at 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.
Kathleen B Schwarz, MD principal investigator
Johns Hopkins University
11 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 Pegylated Interferon/ribavirin in people with Chronic Hepatitis C, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 11 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 27 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 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 1 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Viral Response (SVR) (time frame: at least 24 weeks after stopping treatment.). 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 NCT00100659, which also lists 9 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 24 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.