Hepatitis C VirusPhase 2HEPCATNCT01170962
Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment
A Phase 2 study testing BMS-790052, peginterferon alfa-2a and ribavirin in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 72 sites in 11 countries.
Trial summary
The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C Virus
- What is being tested?
- BMS-790052, peginterferon alfa-2a and 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
- 512 participants
- Where
- 72 sitesin 11 countries
- Study dates
- Aug 2010to Dec 2012
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects chronically infected with HCV genotype 1
- Non-responder to prior therapy with peginterferon alfa and ribavirin
- HCV RNA viral load of 100,00 IU/mL
- Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population)
- Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma
- Body Mass Index (BMI) of 18 to 35 kg/m2
Who cannot join
- Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening
- Evidence of medical condition associated with chronic liver disease other than HCV
- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Trial locations and contacts
72 sites in 11 countries.
72 sites in 11 countries
United States35 sites
Samuel S. Stratton Vamc
Albany, New York, 12208
North Texas Research Institute
Arlington, Texas, 76012
Transplant Center And Hepatology Clinic, B-154
Aurora, Colorado, 80045
Mercy Medical Center
Baltimore, Maryland, 21202
Digestive Disease Associates, P.A.
Baltimore, Maryland, 21229
University Of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599-7584
Metropolitan Research
Fairfax, Virginia, 22031
University Of Florida Hepatology
Gainesville, Florida, 32610-0277
James Sungsik Park, M.D. C.N.S.C.
Great Neck, New York, 11201
Liver Associates Of Texas
Houston, Texas, 77030
St. Luke'S Episcopal Hospital - Baylor College Of Medicine
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Scripps Clinic
La Jolla, California, 92037
CLI
Los Angeles, California, 90048
Johns Hopkins Medical Institutions
Lutherville, Maryland, 21093
Dean Clinic
Madison, Wisconsin, 53715
Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, 36116
Upper Delaware Valley Infectious Diseases, Pc
Monticello, New York, 12701
Nashville Medical Research Institute
Nashville, Tennessee, 37205
Yale University School Of Medicine
New Haven, Connecticut, 06520
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
University Gastroenterology
Providence, Rhode Island, 02905
University Of Rochester Medical Center
Rochester, New York, 14642
Alamo Medical Research
San Antonio, Texas, 78215
Desta Digestive Disease Medical Center
San Diego, California, 92114
University Of California At San Francisco
San Francisco, California, 94110
California Pacific Medical Center
San Francisco, California, 94115
Kaiser Permanente Medical Center
San Francisco, California, 94118
Miami Research Associates
South Miami, Florida, 33143
The Research Institute
Springfield, Massachusetts, 01105
Saint Louis University
St Louis, Missouri, 63104
Carolinas Center For Liver Disease
Statesville, North Carolina, 28677
James J Peters Vamc
The Bronx, New York, 10468
Healthcare Research Consultants
Tulsa, Oklahoma, 74135
France7 sites
Local Institution
Clichy, 92118
Local Institution
Créteil, 94010
Local Institution
Lyon, 69317
Local Institution
Nice, 06202
Local Institution
Paris, 75013
Local Institution
Paris, 75679
Local Institution
Vandœuvre-lès-Nancy, 54511
Australia6 sites
Local Institution
Clayton, Victoria, 3168
Local Institution
Fremantle, Western Australia, 6160
Local Institution
Heidelberg, Victoria, 3084
Local Institution
Perth, Western Australia, 6001
Local Institution
Prahan, Victoria, 3004
Local Institution
Randwick, New South Wales, 2031
Canada5 sites
Local Institution
Edmonton, Alberta, T6G 2B7
Local Institution
Toronto, Ontario, M5G 2N2
Local Institution
Toronto, Ontario, M5T 2S8
Local Institution
Vancouver, British Columbia, V6Z 2K5
Local Institution
Victoria, British Columbia, V8V 3P9
Germany4 sites
Local Institution
Essen, 45122
Local Institution
Frankfurt, 60590
Local Institution
Hamburg, 20099
Local Institution
Hanover, 30625
Argentina3 sites
Local Institution
Ciudad de Buenos Aires, Buenos Aires, C1121ABE
Local Institution
Ciudad de Buenos Aires, Buenos Aires, C1181ACH
Local Institution
Prov de Santa Fe, Santa Fe Province, 2000
Denmark3 sites
Local Institution
Aarhus, 8200
Local Institution
Hvidovre, 2650
Local Institution
Odense, 5000
Mexico3 sites
Local Institution
Cuernavaca, Morelos, 62170
Local Institution
Guadalajara, Jalisco, 44160
Local Institution
Monterrey, Nuevo León, 64710
Italy2 sites
Local Institution
Cisanello (pisa), 56124
Local Institution
Pavia, 27100
Puerto Rico2 sites
Instituto De Investigacion Cientifica Del Sur
Ponce, 00780
Local Institution
San Juan, 00927
Sweden2 sites
Local Institution
Gothenburg, SE-416 85
Local Institution
Stockholm, 14186
About this study
Official title: A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy
The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.
- Conditions
- Hepatitis C Virus
- Being tested
- BMS-790052, Placebo, peginterferon alfa-2a, ribavirin
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-790052Drug
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
BMS-790052Drug
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
PlaceboDrug
Film coated tablet, Oral, 0mg, Once daily, 24 weeks
peginterferon alfa-2aDrug
Also called Pegasys®
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
ribavirinDrug
Also called Copegus®
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin | Experimental | (prior null responders) Receives: Drug: BMS-790052; Drug: peginterferon alfa-2a; Drug: ribavirin |
| Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin | Experimental | (prior null responders) Receives: Drug: BMS-790052; Drug: peginterferon alfa-2a; Drug: ribavirin |
| Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin | Experimental | (prior partial responders) Receives: Drug: BMS-790052; Drug: peginterferon alfa-2a; Drug: ribavirin |
| Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin | Experimental | (prior partial responders) Receives: Drug: BMS-790052; Drug: peginterferon alfa-2a; Drug: ribavirin |
| Arm 5: Placebo plus peginterferon alfa-2a and ribavirin | Experimental | (prior partial responders only) Receives: Drug: Placebo; 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 Extended Rapid Virologic Response (eRVR)
eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Measured: Week 4, Week 12
Percentage of Participants With 24-week Sustained Virologic Response (SVR24)
SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Measured: Follow-up Week 24
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Measured: From first dose to last dose plus 7 days, up to 49 weeks
Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Measured: From day 8 post last dose of treatment up-to Week 72
Secondary outcomes (5)
Percentage of Participants With Rapid Virologic Response (RVR)
RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 4. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Measured: Week 4
Percentage of Participants With Complete Early Virologic Response (cEVR)
cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Measured: Week 12
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)
SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Measured: Follow-up Week 12
Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.
Measured: Baseline to follow-up Week 48
Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H.
Measured: Baseline to follow-up Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2012
- Study completionDec 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 VirusStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170962
- Sponsor's protocol ID
- AI444-011
- Other IDs
- 2010-019378-34
- Acronym
- HEPCAT
- Status last verified
- Sep 2015
- First submitted
- 16 Jul 2010
- Last updated
- 12 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy
- ClinicalTrials.gov ID
- NCT01170962
- Acronym / sponsor ID
- HEPCAT / AI444-011
- Conditions
- Hepatitis C Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Posted 12 Oct 2015
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 whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin | Experimental | Drug: BMS-790052, Drug: peginterferon alfa-2a, Drug: ribavirin(prior null responders) |
| Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin | Experimental | Drug: BMS-790052, Drug: peginterferon alfa-2a, Drug: ribavirin(prior null responders) |
| Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin | Experimental | Drug: BMS-790052, Drug: peginterferon alfa-2a, Drug: ribavirin(prior partial responders) |
| Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin | Experimental | Drug: BMS-790052, Drug: peginterferon alfa-2a, Drug: ribavirin(prior partial responders) |
| Arm 5: Placebo plus peginterferon alfa-2a and ribavirin | Experimental | Drug: Placebo, Drug: peginterferon alfa-2a, Drug: ribavirin(prior partial responders only) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects chronically infected with HCV genotype 1
- Non-responder to prior therapy with peginterferon alfa and ribavirin
- HCV RNA viral load of 100,00 IU/mL
- Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population)
- Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma
Key exclusion criteria (3 listed)
- Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening
- Evidence of medical condition associated with chronic liver disease other than HCV
- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
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 |
|---|---|---|
| BMS-790052Film coated tablet, Oral, 20 mg, once daily, 24 weeks | Drug | Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin, Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin |
| BMS-790052Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks | Drug | Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin, Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin |
| PlaceboFilm coated tablet, Oral, 0mg, Once daily, 24 weeks | Drug | Arm 5: Placebo plus peginterferon alfa-2a and ribavirin |
| peginterferon alfa-2aAlso: Pegasys®Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks | Drug | Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin, Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin, Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin, Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin, Arm 5: Placebo plus peginterferon alfa-2a and ribavirin |
| ribavirinAlso: Copegus®Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks | Drug | Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin, Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin, Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin, Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin, Arm 5: Placebo plus peginterferon alfa-2a and ribavirin |
Primary outcome
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Time frame: Week 4, Week 12
eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Percentage of Participants With 24-week Sustained Virologic Response (SVR24)
Time frame: Follow-up Week 24
SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment
Time frame: From first dose to last dose plus 7 days, up to 49 weeks
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period
Time frame: From day 8 post last dose of treatment up-to Week 72
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
5 secondary outcomes
Percentage of Participants With Rapid Virologic Response (RVR)
Time frame: Week 4
Percentage of Participants With Complete Early Virologic Response (cEVR)
Time frame: Week 12
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)
Time frame: Follow-up Week 12
Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Time frame: Baseline to follow-up Week 48
Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Time frame: Baseline to follow-up Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hepatitis C Virus
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
72 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-790052, peginterferon alfa-2a and ribavirin in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 72 sites in 11 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 6 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 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, France, Australia, Canada, Germany and 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 12 Oct 2015). 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 Extended Rapid Virologic Response (eRVR) (time frame: Week 4, Week 12). The study lists 4 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 12 Oct 2015.