Hepatitis C, ChronicPhase 3NCT00623428
A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response
A Phase 3 study testing peginterferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 101 sites in 10 countries.
Trial summary
This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- peginterferon alfa-2a and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 101 sitesin 10 countries
- Study dates
- Jun 2008to May 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, >=18 years of age;
- serological evidence of chronic hepatitis C (CHC);
- CHC genotype 2 or 3;
- receiving PEGASYS + Copegus according to local standard of care and no rapid viral response (RVR);
- compensated liver disease.
Who cannot join
- pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
- coinfection with hepatitis A or B, or human immunodeficiency virus (HIV);
- history or other evidence of decompensated liver disease.
Trial locations and contacts
101 sites in 10 countries.
101 sites in 10 countries
United States38 sites
Study site
Albuquerque, New Mexico, 87131
Study site
Asheville, North Carolina, 28801
Study site
Atlanta, Georgia, 30308
Study site
Aurora, Colorado, 80045
Study site
Baton Rouge, Louisiana, 70890
Study site
Birmingham, Alabama, 35294
Study site
Boston, Massachusetts, 02114
Study site
Chapel Hill, North Carolina, 27599-7080
Study site
Charlottesville, Virginia, 22908
Study site
Egg Harbour Township, New Jersey, 08234
Study site
Fairfax, Virginia, 22031
Study site
Fort Sam Houston, Texas, 78234-3879
Study site
Hackensack, New Jersey, 07601
Study site
Honolulu, Hawaii, 96813
Study site
Jacksonville, Florida, 32256
Study site
Kingsport, Tennessee, 37660
Study site
La Jolla, California, 92037-1030
Study site
Lancaster, California, 93534
Study site
Long Beach, California, 90822
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Los Angeles, California, 90048
Study site
Los Angeles, California, 90057
Study site
Marietta, Georgia, 30060
Study site
New York, New York, 10016
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Oklahoma City, Oklahoma, 73112-4481
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Opelousas, Louisiana, 70520
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Orlando, Florida, 32803
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Portland, Oregon, 97239
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Richmond, Virginia, 23249
Study site
Sacramento, California, 95816
Study site
Sacramento, California, 95817
Study site
Salt Lake City, Utah, 84132
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San Diego, California, 92103-8465
Study site
St Louis, Missouri, 63104
Study site
St Louis, Missouri, 63110
Study site
Syracuse, New York, 13210
Study site
Torrance, California, 90505
Study site
Tupelo, Mississippi, 38801
Study site
Winston-Salem, North Carolina, 27103
Germany18 sites
Study site
Berlin, 10969
Study site
Berlin, 13353
Study site
Bonn, 53127
Study site
Cologne, 50937
Study site
Düsseldorf, 40225
Study site
Düsseldorf, 40237
Study site
Frankfurt am Main, 60590
Study site
Freiburg im Breisgau, 79106
Study site
Giessen, 35392
Study site
Hamburg, 20099
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Heidelberg, 69120
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Jena, 07747
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Kiel, 24105
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Mainz, 55101
Study site
München, 81675
Study site
Offenburg, 77654
Study site
Tübingen, 72076
Study site
Ulm, 89081
Brazil12 sites
Study site
Brasília, 70335-000
Study site
Campinas, 13012-970
Study site
Campinas, 13081-970
Study site
Porto Alegre, 90020-090
Study site
Porto Alegre, 90035-003
Study site
Ribeirão Preto, 14049-900
Study site
Rio de Janeiro, 20020-022
Study site
Santo André, 09060-650
Study site
São Luís, 78048-790
Study site
São Paulo, 04040-003
Study site
Sorocaba, 18047-600
Study site
Vitória, 29043-260
Belgium7 sites
Study site
Antwerp, 2650
Study site
Brussels, 1000
Study site
Brussels, 1020
Study site
Brussels, 1070
Study site
Ghent, 9000
Study site
Kortrijk, 8500
Study site
Liège, 4000
Austria6 sites
Study site
Graz, 8036
Study site
Innsbruck, 6020
Study site
Linz, 4010
Study site
Oberndorf, 5110
Study site
Vienna, 1090
Study site
Vienna, 1160
Mexico6 sites
Study site
Guadalajara, 44160
Study site
Guadalajara, 44670
Study site
Mexicali, 21000
Study site
Mexico City, 11649
Study site
Mexico City, 14050
Study site
Puebla City, 72560
Australia5 sites
Study site
Darlinghurst, 2010
Study site
Fremantle, 6160
Study site
Melbourne, 3186
Study site
Nedlands, 6009
Study site
Sydney, 2139
Canada4 sites
Study site
Edmonton, Alberta, T6G 2B7
Study site
Hamilton, Ontario, L8N 4A6
Study site
Mississauga, Ontario, L5M 4N4
Study site
Vancouver, British Columbia, V6Z 2K5
Switzerland4 sites
Study site
Lausanne, 1005
Study site
Lugano, 6903
Study site
Sankt Gallen, 9007
Study site
Zurich, 8091
About this study
Official title: A Randomized, Open-label Study of the Effects of 24 vs 48 Weeks of Combination Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) Plus COPEGUS (Ribavirin) on Sustained Virological Response in Patients With Chronic Hepatitis C, Genotype 2 or 3 Who do Not Achieve a Rapid Viral Response
This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.
Read the detailed description
During a pre-study run-in phase patients with chronic hepatitis C genotype 2/3, who had started therapy with PEG-IFN alfa-2a plus ribavirin according to local standard of care and did not achieve a rapid viral response (RVR) (defined as Hepatitis C virus (HCV) RNA <15 IU/mL at Week 4 of treatment measured with the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test) were eligible for the study and entered the screening phase between treatment Week 4 and 8 as soon as the result of the Week 4 HCV RNA test was available.
Eligible patients entered the study and continued with the dose regimens of PEG-IFN alfa-2a and ribavirin they were taking prior to enrolment into the trial up to Week 24 of treatment. Patients who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24, were randomized at treatment Week 24 to one of the two study groups. Upon randomization, participants either stopped treatment (equaling 24 weeks of treatment) or continued treatment for another 24 weeks (equaling 48 weeks of treatment). A treatment free follow-up period of 24 weeks (for participants in the 48-week treatment group) or 48 weeks (participants in the 24-week treatment group) completed the study.
- Conditions
- Hepatitis C, Chronic
- Being tested
- peginterferon alfa-2a, Ribavirin
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peginterferon alfa-2aDrug
Also called Pegasys®, PEG-IFN alfa-2a
RibavirinDrug
Also called Copegus®
| Study group | Role | What they receive |
|---|---|---|
| PEG-IFN alfa-2a + Ribavirin for 24 weeks | Experimental | After 24 weeks of treatment with pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period. Receives: Drug: peginterferon alfa-2a; Drug: Ribavirin |
| PEG-IFN alfa-2a + Ribavirin for 48 weeks | Active comparator | After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period. Receives: Drug: peginterferon alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment
Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period.
Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis.
Measured: 24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.
Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment
Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders.
Measured: 24 weeks after actual end of treatment (range from Week 48 to Week 72).
Secondary outcomes (5)
Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation
Virological response 72 weeks after treatment initiation is defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 48 weeks post completion of the 24 week treatment period and 24 weeks post completion of the 48 week treatment period.
Participants without Week 72 measurements were considered non-responders in the analysis.
Measured: Week 72
Percentage of Participants With Virological Response at End of Treatment
Virological response at the end of treatment was defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication.
Measured: End of Treatment (Week 24 and Week 48 for each treatment group respectively).
Percentage of Participants With Virological Relapse
Virological relapse defined as the percentage of participants with a virological response at end of treatment but who did not have a sustained virological response 24 weeks after the end of treatment.
Virological response at end of treatment is defined as a single last HCV RNA measurement <15 IU/ml measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test at the day of last dose of study medication.
Sustained virological response 24 weeks after the actual treatment end (SVR24) is defined as a single last HCV RNA measurement <15 IU/ml at least 20 weeks after treatment end.
Measured: End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).
Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment
Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 12 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 12 weeks after actual end of treatment were used in the analysis. Participants without a 12-week post treatment measurement are considered non-responders.
Measured: 12 weeks after actual end of treatment (range from Week 36 to Week 60)
Number of Participants With Adverse Events (AEs)
An AE was defined as a sign or symptom, including intercurrent illness, that occurred during the course of the clinical study after treatment had started. A related AE is an event assessed by the Investigator to be remotely, possibly, or probably related to study treatment according to criteria provided in the protocol. A severe AE was an event graded by the Investigator as "incapacitating with inability to work or perform normal daily activity". A serious AE (SAE) was defined as any experience that suggests a significant hazard, contraindication, side effect or precaution. This includes any experience which was fatal; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/ birth defect; was medically significant or required intervention to prevent one or other of the outcomes listed above.
Measured: From Week 1 through Week 72.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2012
- Study completionMay 2012
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.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623428
- Sponsor's protocol ID
- MV21371
- Other IDs
- 2007-004993-15
- Status last verified
- Jul 2013
- First submitted
- 18 Feb 2008
- Last updated
- 22 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study of the Effects of 24 vs 48 Weeks of Combination Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) Plus COPEGUS (Ribavirin) on Sustained Virological Response in Patients With Chronic Hepatitis C, Genotype 2 or 3 Who do Not Achieve a Rapid Viral Response
- ClinicalTrials.gov ID
- NCT00623428
- Acronym / sponsor ID
- MV21371
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Feb 2008 (estimated)
- Results
- Posted 24 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.
Detailed description
During a pre-study run-in phase patients with chronic hepatitis C genotype 2/3, who had started therapy with PEG-IFN alfa-2a plus ribavirin according to local standard of care and did not achieve a rapid viral response (RVR) (defined as Hepatitis C virus (HCV) RNA <15 IU/mL at Week 4 of treatment measured with the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test) were eligible for the study and entered the screening phase between treatment Week 4 and 8 as soon as the result of the Week 4 HCV RNA test was available.
Eligible patients entered the study and continued with the dose regimens of PEG-IFN alfa-2a and ribavirin they were taking prior to enrolment into the trial up to Week 24 of treatment. Patients who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24, were randomized at treatment Week 24 to one of the two study groups. Upon randomization, participants either stopped treatment (equaling 24 weeks of treatment) or continued treatment for another 24 weeks (equaling 48 weeks of treatment). A treatment free follow-up period of 24 weeks (for participants in the 48-week treatment group) or 48 weeks (participants in the 24-week treatment group) completed the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-IFN alfa-2a + Ribavirin for 24 weeks | Experimental | Drug: peginterferon alfa-2a, Drug: RibavirinAfter 24 weeks of treatment with pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period. |
| PEG-IFN alfa-2a + Ribavirin for 48 weeks | Active comparator | Drug: peginterferon alfa-2a, Drug: RibavirinAfter 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients, >=18 years of age;
- serological evidence of chronic hepatitis C (CHC);
- CHC genotype 2 or 3;
- receiving PEGASYS + Copegus according to local standard of care and no rapid viral response (RVR);
- compensated liver disease.
Key exclusion criteria (3 listed)
- pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
- coinfection with hepatitis A or B, or human immunodeficiency virus (HIV);
- history or other evidence of decompensated 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-2aAlso: Pegasys®, PEG-IFN alfa-2a | Drug | PEG-IFN alfa-2a + Ribavirin for 24 weeks, PEG-IFN alfa-2a + Ribavirin for 48 weeks |
| RibavirinAlso: Copegus® | Drug | PEG-IFN alfa-2a + Ribavirin for 24 weeks, PEG-IFN alfa-2a + Ribavirin for 48 weeks |
Primary outcome
Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment
Time frame: 24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.
Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period. Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis.
Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment
Time frame: 24 weeks after actual end of treatment (range from Week 48 to Week 72).
Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders.
5 secondary outcomes
Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation
Time frame: Week 72
Percentage of Participants With Virological Response at End of Treatment
Time frame: End of Treatment (Week 24 and Week 48 for each treatment group respectively).
Percentage of Participants With Virological Relapse
Time frame: End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).
Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment
Time frame: 12 weeks after actual end of treatment (range from Week 36 to Week 60)
Number of Participants With Adverse Events (AEs)
Time frame: From Week 1 through Week 72.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trials study director
Hoffmann-La Roche
101 sites in 10 countries: 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, Chronic, run by Hoffmann-La Roche at 101 sites in 10 countries.
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 5 inclusion and 3 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 22 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 101 sites in United States, Germany, Brazil, Belgium, Austria and 5 more countries. 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?
Yes. Results are posted in the registry (first posted 24 Jun 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?
Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment (time frame: 24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.). The study lists 2 primary outcomes in all. 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 22 Jul 2013.