Hepatitis CPhase 2NCT00420784
A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)
A Phase 2 study testing Telaprevir, Ribavirin and Pegylated Interferon Alfa 2a in people with Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 53 sites in 5 countries.
Trial summary
The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral… 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?
- Telaprevir, Ribavirin and Pegylated Interferon Alfa 2a
- 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
- 465 participants
- Where
- 53 sitesin 5 countries
- Study dates
- Feb 2007to Apr 2009
- 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
- Males and females between 18 and 70 years old
- Detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) greater than or equal to (>=) 10,000 international units per milliliter (IU/mL)
- Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of pegylated interferon alfa 2a with ribavirin
- Cannot also be infected with Human Immunodeficiency Virus or hepatitis B
- Must be judged to be in general good health and able to receive Pegasys® and Copegus®
- No drug or alcohol abuse in the last year
- Must agree to use two effective methods of birth control during the study and for 6 months after you stop taking study medication. One of the methods needs to be a 'barrier' method (condom or diaphragm)
- If you are a woman, you cannot be in this study if you are pregnant or nursing
Who cannot join
- Participation in any clinical trial of a HCV protease inhibitor of any duration
- Prior response to therapy and failure to achieve SVR which was due to treatment non-compliance
- Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
- Diagnosed or suspected hepatocellular carcinoma
- History of or current evidence of decompensated liver disease
- Participation in any clinical trial of an investigational drug within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)
Trial locations and contacts
53 sites in 5 countries.
53 sites in 5 countries
United States41 sites
Study site
Albuquerque, New Mexico
Study site
Annandale, Virginia
Study site
Atlanta, Georgia
Johns Hopkins University
Baltimore, Maryland
Study site
Bardenton, Florida
Gulf Coast Research, LLC
Baton Rouge, Louisiana
Birmingham Gastroenterology Associates
Birmingham, Alabama
Beth Isreal Deaconess Medical Center
Boston, Massachusetts
Study site
Chicago, Illinois
University Internal Medicine Associates, Inc.
Cincinnati, Ohio
Cleveland Clinic
Cleveland, Ohio
Columbia Gastroenterology Associates, PA
Columbia, South Carolina
Liver Institute at Methodist Dallas
Dallas, Texas
University of Colorado Health Sciences Center
Denver, Colorado
Henry Ford Hospital
Detroit, Michigan
Study site
Durham, North Carolina
Study site
Englewood, Colorado
Metropolitan Research
Fairfax, Virginia
University of Florida
Gainesville, Florida
Memphis Gastroenterology Group
Germantown, Tennessee
Study site
Hershey, Pennsylvania
Advanced Liver Therapies
Houston, Texas
Study site
Indianapolis, Indiana
Borland-Groover Clinic
Jacksonville, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida
Cedars-Sinai Medical Center
Los Angeles, California, 90048
USC
Los Angeles, California
North Shore University Hospital
Manhasset, New York
Study site
Miami, Florida
Study site
New York, New York
Study site
Omaha, Nebraska
Study site
Pittsburgh, Pennsylvania
Virology Treatment Center, Maine Medical Center
Portland, Maine
Study site
Richmond, Virginia
Alamo Medical Research
San Antonio, Texas
Kaiser Permanente Hepatology Research
San Diego, California
University of California, San Diego
San Diego, California
University of California San Francisco
San Francisco, California
University Hepatitis Center at Bach & Godofsky
Sarasota, Florida
Study site
Seattle, Washington
Saint Louis University
St Louis, Missouri
Canada6 sites
University of Calgary Medical Clinic - Health Science Centre
Calgary, Alberta, T2N 4N1
Study site
Edmonton, Alberta
Toronto Western Hospital
Toronto, Ontario
Study site
Toronto, Ontario
BC Hepatitis Program
Vancouver, British Columbia
Study site
Winnipeg, Manitoba
Netherlands3 sites
Academic Medical Center
Amsterdam
Leiden University Medical Center
Leiden
Erasmus MC University Medical Center
Rotterdam
Germany2 sites
Universitatsmedizin Berlin
Berlin
University Clinic Frankfurt, Department of Internal Medicine
Frankfurt
About this study
Official title: A Phase 2 Study of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response With a Prior Course of Interferon Based Therapy
The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.
- Conditions
- Hepatitis C
- Being tested
- Telaprevir, Ribavirin, Pegylated Interferon Alfa 2a, Matching Placebo
- Keywords
- Genotype 1
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelaprevirDrug
Also called VX-950
tablet
RibavirinDrug
Also called RBV
tablet
Pegylated Interferon Alfa 2aDrug
Also called Peg-IFN-alfa-2a
Solution for injection
Matching PlaceboDrug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week | Experimental | Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks. Receives: Drug: Telaprevir; Drug: Ribavirin; Drug: Pegylated Interferon Alfa 2a |
| Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week | Experimental | Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Receives: Drug: Telaprevir; Drug: Ribavirin; Drug: Pegylated Interferon Alfa 2a |
| Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week | Experimental | Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks. Receives: Drug: Telaprevir; Drug: Pegylated Interferon Alfa 2a |
| PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week | Placebo comparator | Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Receives: Drug: Ribavirin; Drug: Pegylated Interferon Alfa 2a; Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Measured: 24 weeks after the completion of study drug dosing (up to Week 72)
Secondary outcomes (5)
Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Measured: Completion of study drug dosing (up to Week 48)
Percentage of Subjects With Undetectable Plasma HCV RNA
Percentage of subjects with undetectable HCV RNA at 24 weeks after last dose of study drug for treatment group "PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week" and at 48 weeks after last dose of study drug for treatment groups "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week", "Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week" and "Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week" were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Measured: Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
Measured: Baseline up to 2 weeks after last dose of study drug (up to Week 50)
Number of Subjects With Viral Relapse
Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Measured: After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.
Measured: Week 2, 4, 8, 12, 16, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2008
- Study completionApr 2009
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 (2)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 Vertex Pharmaceuticals IncorporatedThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Vertex Pharmaceuticals Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420784
- Sponsor's protocol ID
- VX06-950-106
- Status last verified
- Jul 2014
- First submitted
- 8 Jan 2007
- Last updated
- 5 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Li S, Zhu J, Zhang W, Chen Y, Zhang K, Popescu LM, Ma X, Lau WB, Rong R, Yu X, Wang B, Li Y, Xiao C, Zhang M, Wang S, Yu L, Chen AF, Yang X, Cai J. Signature microRNA expression profile of essential hypertension and its novel link to human cytomegalovirus infection. Circulation. 2011 Jul 12;124(2):175-84. doi: 10.1161/CIRCULATIONAHA.110.012237. Epub 2011 Jun 20.
PubMed 21690488McHutchison JG, Manns MP, Muir AJ, Terrault NA, Jacobson IM, Afdhal NH, Heathcote EJ, Zeuzem S, Reesink HW, Garg J, Bsharat M, George S, Kauffman RS, Adda N, Di Bisceglie AM; PROVE3 Study Team. Telaprevir for previously treated chronic HCV infection. N Engl J Med. 2010 Apr 8;362(14):1292-303. doi: 10.1056/NEJMoa0908014.
PubMed 20375406
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response With a Prior Course of Interferon Based Therapy
- ClinicalTrials.gov ID
- NCT00420784
- Acronym / sponsor ID
- VX06-950-106
- Conditions
- Hepatitis C
- Keywords
- Genotype 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Posted 21 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week | Experimental | Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2aSingle loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks. |
| Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week | Experimental | Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2aSingle loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. |
| Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week | Experimental | Drug: Telaprevir, Drug: Pegylated Interferon Alfa 2aSingle loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks. |
| PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week | Placebo comparator | Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a, Drug: Matching PlaceboPlacebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females between 18 and 70 years old
- Detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) greater than or equal to (>=) 10,000 international units per milliliter (IU/mL)
- Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of pegylated interferon alfa 2a with ribavirin
- Cannot also be infected with Human Immunodeficiency Virus or hepatitis B
- Must be judged to be in general good health and able to receive Pegasys® and Copegus®
Key exclusion criteria (6 listed)
- Participation in any clinical trial of a HCV protease inhibitor of any duration
- Prior response to therapy and failure to achieve SVR which was due to treatment non-compliance
- Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
- Diagnosed or suspected hepatocellular carcinoma
- History of or current 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 |
|---|---|---|
| TelaprevirAlso: VX-950tablet | Drug | Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week, Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week |
| RibavirinAlso: RBVtablet | Drug | PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week |
| Pegylated Interferon Alfa 2aAlso: Peg-IFN-alfa-2aSolution for injection | Drug | PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week, Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week |
| Matching PlaceboTablet | Drug | PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week |
Primary outcome
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing
Time frame: 24 weeks after the completion of study drug dosing (up to Week 72)
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
5 secondary outcomes
Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing
Time frame: Completion of study drug dosing (up to Week 48)
Percentage of Subjects With Undetectable Plasma HCV RNA
Time frame: Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 2 weeks after last dose of study drug (up to Week 50)
Number of Subjects With Viral Relapse
Time frame: After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Time frame: Week 2, 4, 8, 12, 16, 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21690488Li S, Zhu J, Zhang W, Chen Y, Zhang K, Popescu LM, Ma X, Lau WB, Rong R, Yu X, Wang B, Li Y, Xiao C, Zhang M, Wang S, Yu L, Chen AF, Yang X, Cai J. Signature microRNA expression profile of essential hypertension and its novel link to human cytomegalovirus infection. Circulation. 2011 Jul 12;124(2):175-84. doi: 10.1161/CIRCULATIONAHA.110.012237. Epub 2011 Jun 20.
- Derived from this study: PubMed 20375406McHutchison JG, Manns MP, Muir AJ, Terrault NA, Jacobson IM, Afdhal NH, Heathcote EJ, Zeuzem S, Reesink HW, Garg J, Bsharat M, George S, Kauffman RS, Adda N, Di Bisceglie AM; PROVE3 Study Team. Telaprevir for previously treated chronic HCV infection. N Engl J Med. 2010 Apr 8;362(14):1292-303. doi: 10.1056/NEJMoa0908014.
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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.
Medical Monitor study director
Vertex Pharmaceuticals Incorporated
53 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telaprevir, Ribavirin and Pegylated Interferon Alfa 2a in people with Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 53 sites in 5 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 8 inclusion and 6 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 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Canada, Netherlands, Germany, Puerto Rico. 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 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 21 Jul 2011). 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 Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (time frame: 24 weeks after the completion of study drug dosing (up to Week 72)). 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 NCT00420784, which also lists 2 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 5 Aug 2014.