Hepatitis C, ChronicPhase 3NCT01054573
VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo
A Phase 3 study testing Telaprevir, pegylated interferon (Peg-IFN) alfa-2a and ribavirin (RBV) in people with Hepatitis C, Chronic, run by Janssen Infectious Diseases BVBA at 48 sites in 15 countries.
Trial summary
The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Telaprevir, pegylated interferon (Peg-IFN) alfa-2a and ribavirin (RBV)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 48 sitesin 15 countries
- Study dates
- Apr 2010to 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient from the control group of the C216 study who failed therapy for virologic reasons
- Patient must have completed all assessments in the C216 trial
- Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Who cannot join
- Patient received any direct acting anti-viral HCV therapy after discontinuation of the C216 trial
- Patient has history of decompensated liver disease
- Patient has history of acute or chronic pancreatitis
- Patient has condition that requires use of systemic corticosteroids
- Patient who prematurely stopped medication for non-compliance or for whom it would be unsafe to repeat treatment
- Patient has history of decompensated liver disease or history of cirrhosis with hepatocellular carcinoma
Trial locations and contacts
48 sites in 15 countries.
48 sites in 15 countries
United States14 sites
Study site
Atlanta, Georgia
Study site
Bradenton, Florida
Study site
Chapel Hill, North Carolina
Study site
Columbia, South Carolina
Study site
Coronado, California
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Kansas City, Missouri
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
New York, New York
Study site
Philadelphia, Pennsylvania
Study site
San Antonio, Texas
Study site
San Francisco, California
Germany6 sites
Study site
Berlin
Study site
Cologne
Study site
Frankfurt
Study site
Hamburg
Study site
Hanover
Study site
München
Australia4 sites
Study site
Adelaide
Study site
Clayton
Study site
Darlinghurst
Study site
Perth
France4 sites
Study site
Clichy
Study site
Créteil
Study site
Lille
Study site
Pessac
Brazil3 sites
Study site
Distrito Barao Geraldo-Campina
Study site
Salvador
Study site
São Paulo
About this study
Official title: An Open-label, Single-arm, Roll-over Trial of Telaprevir in Combination With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) for Subjects From the Control Group of the VX- 950-TiDP24-C216 Trial Who Failed Therapy for Virologic Reasons
The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.
Read the detailed description
This is an open-label (i.e all people involved know the identity of the intervention), single-arm, roll-over trial of telaprevir in combination with pegylated interferon (Peg-IFN) alfa-2a and ribavirin (RBV). The purpose of the trial is to provide access to telaprevir for patients who were randomized to the control group in the VX-950-TiDP24-C216 trial (referred to as C216 trial hereafter) and who failed therapy for virologic reasons. The efficacy, safety, and tolerability of telaprevir in combination with Peg IFN alfa 2a and RBV will be evaluated. In addition, amino acid changes from baseline in the HCV NS3 (i.e protein associated with the hepatitis C virus) protease domain will be evaluated. The trial will consist of a screening period of approximately 28 days, a 48-week treatment period, and a 24-week follow-up period. It is expected that approximately 120 patients could be eligible for enrollment. Since the C216 trial is blinded until all patients reach Week 72 (or have discontinued earlier), patients can only enter the current trial upon invitation. The investigator will receive an invitation sent by the unblinded independent virology monitor of the C216 trial for those patients of the C216 trial who were randomized to the control group and who failed therapy for virologic reasons. Next to this invitation, the patient will need to fulfill the inclusion and exclusion criteria of the current trial in order to be eligible to participate. The screening visit for the current trial can only occur after the patient completes all assessments in the C216 trial, including the Safety Follow-up Visit. Patients must not enter this trial later than 80 weeks after their first dose in the C216 trial. In the current trial, all patients will receive 12 weeks of telaprevir 750 mg every 8 hours (q8h) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180 microgram once weekly and 1,000 or 1,200 mg/day (weight based), respectively, followed by 36 weeks of Peg IFN alfa 2a and RBV at standard doses. Patients with hepatitis C virus RNA levels < 25 IU/mL undetectable at the end of treatment (Week 48 or having discontinued earlier) will be followed for 24 weeks after the last dose of study medication to assess sustained virologic response (SVR). Safety/tolerability assessments will be performed and adverse events (AEs), regardless of severity, will be collected continuously until the Safety Follow-up Visit, scheduled 4 weeks after the last dose of study medication. Thereafter, only serious adverse events (SAEs) will be reported. All patients will receive 12 weeks of telaprevir 750 mg q8h (orally) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180 microgram once weekly (injection) and 1,000 or 1,200 mg/day (weight-based) (orally), respectively, followed by 36 weeks of Peg IFN alfa-2a and RBV at standard doses.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Telaprevir, pegylated interferon (Peg-IFN) alfa-2a, ribavirin (RBV)
- Keywords
- Hepatitis C, Chronic, Telaprevir, Roll-over study
- 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.
TelaprevirDrug
750 mg orally every 8 hours (q8h) for 12 weeks
pegylated interferon (Peg-IFN) alfa-2aDrug
180 microgram (mcg) by subcutaneous injection once weekly for 48 weeks.
ribavirin (RBV)Drug
1,000 or 1,200 mg/day (weight based) orally twice daily for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Telaprevir + Standard Treatment | Experimental | Telaprevir 750 mg orally (by mouth) every 8h for 12 weeks plus standard treatment. Standard treatment is 180 mcg subcutaneous (under the skin) injection pegylated interferon (Peg-IFN) alfa-2a and 1000-1200 mg twice daily ribavirin (RBV) for 48 weeks. Receives: Drug: Telaprevir; Drug: pegylated interferon (Peg-IFN) alfa-2a; Drug: ribavirin (RBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual)
The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of < 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure.
Measured: End of trial (24 weeks after last dose, administerd at 48 weeks)
Secondary outcomes (9)
The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points
The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels of less than 25 IU/ml, target not detected at different time points during the study. Data was imputed for participants with missing values using the last observation carried forward (LOCF) method for missing values.
Measured: Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation)
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8
The table below shows the percentage of participants at Week 4 or 8 who met a stopping rule defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value >100 IU/mL.
Measured: Week 4, Week 8
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36
The table below shows the percentage of participants at Week 12, 24, and 36 who met a stopping rule. The stopping rule at Week 12 was having hepatitis C virus (HCV) ribonucleic acid (RNA) value of >100 IU/mL and the stopping rule at Weeks 24 or 36 was having a HCV RNA value of >=25 IU/mL.
Measured: Week 12 or Weeks 24 or 36
Percentage of Participants Achieving Rapid Virologic Response (RVR)
The table below shows the percentage of participants who had a rapid virologic response (RVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at Week 4 of treatment).
Measured: Week 4
Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR)
The table below shows the percentage of participants who had a Extended Rapid Virologic Response (eRVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at at Weeks 4 and 12 of treatment).
Measured: Weeks 4 and 12
Percentage of Participants With Viral Breakthrough
The table below shows the percentage of participants with viral breakthrough defined as a confirmed increase >1 log10 in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached during the considered treatment phase up to the considered time point, if the lowest level reached is > 25 IU/mL, or a confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA had previously become <25 IU/mL (detected or target not detected) during the considered treatment phase.
Measured: Week 48 (Period After Telaprevir Intake) and Week 12 (Telaprevir Treatment Phase)
Percentage of Participants Who Relapsed During Follow-Up
The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 24-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).
Measured: During Follow-Up (24 weeks after the last dose of study drug, administerd at 48 weeks)
Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time
The table below shows plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) values measured over time.
Measured: Baseline, Weeks 4, 8, 12, 24, 36, 48
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
The table below shows change from baseline in log 10 plasma HCV RNA values measured over time.
Measured: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startApr 2010
- Primary completionMar 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Infectious Diseases BVBA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vertex Pharmaceuticals Incorporated
- Responsible party
- Sponsor
- Investigators
- Janssen Infectious Diseases BVBA Clinical Trial, Study director, Janssen Infectious Diseases BVBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054573
- Sponsor's protocol ID
- CR016678
- Other IDs
- VX-TiDP24-C219, 2009-012613-21, 2009
- Status last verified
- May 2013
- First submitted
- 21 Jan 2010
- Last updated
- 8 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Susser S, Flinders M, Reesink HW, Zeuzem S, Lawyer G, Ghys A, Van Eygen V, Witek J, De Meyer S, Sarrazin C. Evolution of hepatitis C virus quasispecies during repeated treatment with the NS3/4A protease inhibitor telaprevir. Antimicrob Agents Chemother. 2015 May;59(5):2746-55. doi: 10.1128/AAC.04911-14. Epub 2015 Feb 23.
PubMed 25712364
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Roll-over Trial of Telaprevir in Combination With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) for Subjects From the Control Group of the VX- 950-TiDP24-C216 Trial Who Failed Therapy for Virologic Reasons
- ClinicalTrials.gov ID
- NCT01054573
- Acronym / sponsor ID
- CR016678
- Conditions
- Hepatitis C, Chronic
- Keywords
- Hepatitis C, Chronic, Telaprevir, Roll-over study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Janssen Infectious Diseases BVBAIndustry (pharma, biotech, devices)
- Collaborators
- Vertex Pharmaceuticals Incorporated
- Study start
- Apr 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Posted 19 Apr 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 provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.
Detailed description
This is an open-label (i.e all people involved know the identity of the intervention), single-arm, roll-over trial of telaprevir in combination with pegylated interferon (Peg-IFN) alfa-2a and ribavirin (RBV). The purpose of the trial is to provide access to telaprevir for patients who were randomized to the control group in the VX-950-TiDP24-C216 trial (referred to as C216 trial hereafter) and who failed therapy for virologic reasons. The efficacy, safety, and tolerability of telaprevir in combination with Peg IFN alfa 2a and RBV will be evaluated. In addition, amino acid changes from baseline in the HCV NS3 (i.e protein associated with the hepatitis C virus) protease domain will be evaluated. The trial will consist of a screening period of approximately 28 days, a 48-week treatment period, and a 24-week follow-up period. It is expected that approximately 120 patients could be eligible for enrollment. Since the C216 trial is blinded until all patients reach Week 72 (or have discontinued earlier), patients can only enter the current trial upon invitation. The investigator will receive an invitation sent by the unblinded independent virology monitor of the C216 trial for those patients of the C216 trial who were randomized to the control group and who failed therapy for virologic reasons. Next to this invitation, the patient will need to fulfill the inclusion and exclusion criteria of the current trial in order to be eligible to participate. The screening visit for the current trial can only occur after the patient completes all assessments in the C216 trial, including the Safety Follow-up Visit. Patients must not enter this trial later than 80 weeks after their first dose in the C216 trial. In the current trial, all patients will receive 12 weeks of telaprevir 750 mg every 8 hours (q8h) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180 microgram once weekly and 1,000 or 1,200 mg/day (weight based), respectively, followed by 36 weeks of Peg IFN alfa 2a and RBV at standard doses. Patients with hepatitis C virus RNA levels < 25 IU/mL undetectable at the end of treatment (Week 48 or having discontinued earlier) will be followed for 24 weeks after the last dose of study medication to assess sustained virologic response (SVR). Safety/tolerability assessments will be performed and adverse events (AEs), regardless of severity, will be collected continuously until the Safety Follow-up Visit, scheduled 4 weeks after the last dose of study medication. Thereafter, only serious adverse events (SAEs) will be reported. All patients will receive 12 weeks of telaprevir 750 mg q8h (orally) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180 microgram once weekly (injection) and 1,000 or 1,200 mg/day (weight-based) (orally), respectively, followed by 36 weeks of Peg IFN alfa-2a and RBV at standard doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telaprevir + Standard Treatment | Experimental | Drug: Telaprevir, Drug: pegylated interferon (Peg-IFN) alfa-2a, Drug: ribavirin (RBV)Telaprevir 750 mg orally (by mouth) every 8h for 12 weeks plus standard treatment. Standard treatment is 180 mcg subcutaneous (under the skin) injection pegylated interferon (Peg-IFN) alfa-2a and 1000-1200 mg twice daily ribavirin (RBV) 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 (3 listed)
- Patient from the control group of the C216 study who failed therapy for virologic reasons
- Patient must have completed all assessments in the C216 trial
- Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Key exclusion criteria (6 listed)
- Patient received any direct acting anti-viral HCV therapy after discontinuation of the C216 trial
- Patient has history of decompensated liver disease
- Patient has history of acute or chronic pancreatitis
- Patient has condition that requires use of systemic corticosteroids
- Patient who prematurely stopped medication for non-compliance or for whom it would be unsafe to repeat treatment
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 |
|---|---|---|
| Telaprevir750 mg orally every 8 hours (q8h) for 12 weeks | Drug | Telaprevir + Standard Treatment |
| pegylated interferon (Peg-IFN) alfa-2a180 microgram (mcg) by subcutaneous injection once weekly for 48 weeks. | Drug | Telaprevir + Standard Treatment |
| ribavirin (RBV)1,000 or 1,200 mg/day (weight based) orally twice daily for 48 weeks. | Drug | Telaprevir + Standard Treatment |
Primary outcome
The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual)
Time frame: End of trial (24 weeks after last dose, administerd at 48 weeks)
The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of < 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure.
9 secondary outcomes
The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation)
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8
Time frame: Week 4, Week 8
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36
Time frame: Week 12 or Weeks 24 or 36
Percentage of Participants Achieving Rapid Virologic Response (RVR)
Time frame: Week 4
Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR)
Time frame: Weeks 4 and 12
Percentage of Participants With Viral Breakthrough
Time frame: Week 48 (Period After Telaprevir Intake) and Week 12 (Telaprevir Treatment Phase)
Percentage of Participants Who Relapsed During Follow-Up
Time frame: During Follow-Up (24 weeks after the last dose of study drug, administerd at 48 weeks)
Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, 48
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25712364Susser S, Flinders M, Reesink HW, Zeuzem S, Lawyer G, Ghys A, Van Eygen V, Witek J, De Meyer S, Sarrazin C. Evolution of hepatitis C virus quasispecies during repeated treatment with the NS3/4A protease inhibitor telaprevir. Antimicrob Agents Chemother. 2015 May;59(5):2746-55. doi: 10.1128/AAC.04911-14. Epub 2015 Feb 23.
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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.
Janssen Infectious Diseases BVBA Clinical Trial study director
Janssen Infectious Diseases BVBA
48 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telaprevir, pegylated interferon (Peg-IFN) alfa-2a and ribavirin (RBV) in people with Hepatitis C, Chronic, run by Janssen Infectious Diseases BVBA at 48 sites in 15 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 3 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 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Germany, Australia, France, Belgium and 10 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 19 Apr 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?
The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual) (time frame: End of trial (24 weeks after last dose, administerd at 48 weeks)). 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 NCT01054573, which also lists 1 linked publication.
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 8 May 2013.