Hepatitis C VirusPhase 2NCT01257204
Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
A Phase 2 study testing Daclatasvir, Pegylated interferon alfa-2a and Ribavirin in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 26 sites in 6 countries.
Trial summary
To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin. 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?
- Daclatasvir, Pegylated interferon 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
- 196 participants
- Where
- 26 sitesin 6 countries
- Study dates
- Dec 2010to Sep 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
- Participants chronically infected with hepatitis C virus (HCV) genotype 2 or 3
- No previous exposure to an interferon formulation (ie, interferon alfa, pegylated interferon alfa-2a ) or ribavirin
- Body mass index (BMI) of 18 to 35 kg/m^2, inclusive. BMI=weight (kg)/height (m)^2
- Males and females, 18 - 70 years of age
Who cannot join
- Liver transplant recipients
- Documented or suspected hepatocellular carcinoma
- Evidence of decompensated cirrhosis
- History of chronic hepatitis B virus (HBV). Patients with resolved HBV infection may participate
- Current or known history of cancer
- Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug
Show all 18Show fewer
- Inability to tolerate oral medication
- Poor venous access
- Severe psychiatric disease
- History of chronic pulmonary disease
- History of cardiomyopathy, coronary artery disease (including angina), interventive procedure for coronary artery disease (including angioplasty, stent procedure, or cardiac bypass surgery), ventricular arrhythmia,, or other clinically significant cardiac disease
- History of or current electrocardiogram findings indicative of cardiovascular instability
- Preexisting ophthalmologic disorders considered clinically significant on eye
- History of uncontrolled diabetes mellitus
- Any known contraindication to pegylated interferon alfa-2a or ribavirin not otherwise specified.
- Positive hepatitis B virus surface antigen, HIV-1 or HIV-2 Ab
- Prior exposure to any HCV direct antiviral agent (eg, HCV protease, polymerase, previous nonstructural protein 5A inhibitors)
- Exposure to any investigational drug or placebo
Trial locations and contacts
26 sites in 6 countries.
26 sites in 6 countries
Australia6 sites
Local Institution
Adelaide, South Australia, 5000
Local Institution
Camperdown, NSW 2050
Local Institution
Clayton Vic, Victoria, 3168
Local Institution
Darlinghurst, New South Wales, 2010
Local Institution
Fremantle, Western Australia, 6160
Local Institution
Westmead Nsw, New South Wales, 2145
Canada6 sites
Local Institution
Calgary, Alberta, T2N 4Z6
Local Institution
Edmonton, Alberta, T6G 2B7
Local Institution
Toronto, Ontario, M5G 2N2
Local Institution
Vancouver, British Columbia, V6Z 2K5
Local Institution
Victoria, British Columbia, V8V 3P9
Local Institution
Winnipeg, Manitoba, R3E 3P4
France6 sites
Local Institution
Créteil, 94000
Local Institution
Lille, 59037
Local Institution
Montpellier, 34295
Local Institution
Nice, 06202
Local Institution
Paris, 75679
Local Institution
Pessac, 33604
United States4 sites
Digestive Disease Associates, P.A.
Baltimore, Maryland, 21229
California Liver Institute
Los Angeles, California, 90048
Alamo Medical Research
San Antonio, Texas, 78215
Options Health Research, Llc
Tulsa, Oklahoma, 74104
Italy3 sites
Local Institution
Brescia, 25123
Local Institution
Cisanello (pisa), 56124
Local Institution
Viale Del Policlinico, 155, 00161
About this study
Official title: A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection
To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.
- Conditions
- Hepatitis C Virus
- Being tested
- Placebo, Daclatasvir, Pegylated interferon 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.
PlaceboDrug
Tablets, oral, 0 mg, once daily, for 24 weeks
DaclatasvirDrug
Also called BMS-790052
Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks
Pegylated interferon alfa-2aDrug
Also called Pegasys®
Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks
RibavirinDrug
Also called Copegus®
Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Placebo + Pegylated interferon alfa-2a + Ribavirin Receives: Drug: Placebo; Drug: Pegylated interferon alfa-2a; Drug: Ribavirin |
| 12 Week Cohort | Experimental | Daclatasvir + Pegylated interferon alfa-2a + Ribavirin Receives: Drug: Daclatasvir; Drug: Pegylated interferon alfa-2a; Drug: Ribavirin |
| 16 Week Cohort | Experimental | Daclatasvir + Pegylated interferon alfa-2a + Ribavirin Receives: Drug: Daclatasvir; Drug: Pegylated interferon alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2
SVR24 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, 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
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3
SVR24 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, 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
Secondary outcomes (10)
Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2
RVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, 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 Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3
RVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, 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 Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2
cEVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, 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 Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3
cEVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, 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 Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2
SVR12 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, 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
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3
SVR12 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, 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 Virologic Failure for Hepatitis C Virus (HCV) Genotype 2
Virologic failure was defined as:
- Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment
- <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment
- Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment
- HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)
- Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, after HCV RNA <LLOQ, TND at EOT.
The LLOQ was 25 IU/mL, and <LLOQ, 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: Baseline up to Week 48
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3
Virologic failure was defined as:
- Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment
- <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment
- Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment
- HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)
- Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, after HCV RNA <LLOQ, TND at EOT.
The LLOQ was 25 IU/mL, and <LLOQ, 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: Baseline up to Week 48
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. Mild (Grade 1): awareness of event but easily tolerated; Moderate (Grade 2): discomfort enough to cause some interference with usual activity; Severe (Grade 3): inability to carry out usual activity; Very severe (Grade 4): debilitating, significantly incapacitates participant despite symptomatic therapy. Only Grade 2-4 treatment-related AEs were reported.
Measured: Baseline (Day 1) up to 24 weeks (treatment period)
Number of Participants With Adverse Events (AEs), 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 has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Measured: From end of treatment period up to Week 48 (follow-up period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMay 2012
- Study completionSep 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 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
- 196 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
- NCT01257204
- Sponsor's protocol ID
- AI444-031
- Other IDs
- 2010-022408-28
- Status last verified
- Nov 2015
- First submitted
- 1 Dec 2010
- Last updated
- 14 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dore GJ, Lawitz E, Hezode C, Shafran SD, Ramji A, Tatum HA, Taliani G, Tran A, Brunetto MR, Zaltron S, Strasser SI, Weis N, Ghesquiere W, Lee SS, Larrey D, Pol S, Harley H, George J, Fung SK, de Ledinghen V, Hagens P, McPhee F, Hernandez D, Cohen D, Cooney E, Noviello S, Hughes EA. Daclatasvir plus peginterferon and ribavirin is noninferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection. Gastroenterology. 2015 Feb;148(2):355-366.e1. doi: 10.1053/j.gastro.2014.10.007. Epub 2014 Oct 13.
PubMed 25311593
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection
- ClinicalTrials.gov ID
- NCT01257204
- Acronym / sponsor ID
- AI444-031
- Conditions
- Hepatitis C Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Posted 14 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Placebo, Drug: Pegylated interferon alfa-2a, Drug: RibavirinPlacebo + Pegylated interferon alfa-2a + Ribavirin |
| 12 Week Cohort | Experimental | Drug: Daclatasvir, Drug: Pegylated interferon alfa-2a, Drug: RibavirinDaclatasvir + Pegylated interferon alfa-2a + Ribavirin |
| 16 Week Cohort | Experimental | Drug: Daclatasvir, Drug: Pegylated interferon alfa-2a, Drug: RibavirinDaclatasvir + Pegylated interferon alfa-2a + Ribavirin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants chronically infected with hepatitis C virus (HCV) genotype 2 or 3
- No previous exposure to an interferon formulation (ie, interferon alfa, pegylated interferon alfa-2a ) or ribavirin
- Body mass index (BMI) of 18 to 35 kg/m^2, inclusive. BMI=weight (kg)/height (m)^2
- Males and females, 18 - 70 years of age
Key exclusion criteria (18 listed)
- Liver transplant recipients
- Documented or suspected hepatocellular carcinoma
- Evidence of decompensated cirrhosis
- History of chronic hepatitis B virus (HBV). Patients with resolved HBV infection may participate
- Current or known history of cancer
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 |
|---|---|---|
| PlaceboTablets, oral, 0 mg, once daily, for 24 weeks | Drug | Control |
| DaclatasvirAlso: BMS-790052Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks | Drug | 12 Week Cohort, 16 Week Cohort |
| Pegylated interferon alfa-2aAlso: Pegasys®Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks | Drug | 12 Week Cohort, 16 Week Cohort, Control |
| RibavirinAlso: Copegus®Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks | Drug | 12 Week Cohort, 16 Week Cohort, Control |
Primary outcome
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2
Time frame: Follow-up Week 24
SVR24 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3
Time frame: Follow-up Week 24
SVR24 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
10 secondary outcomes
Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2
Time frame: Week 4
Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3
Time frame: Week 4
Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2
Time frame: Week 12
Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3
Time frame: Week 12
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2
Time frame: Follow-up Week 12
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3
Time frame: Follow-up Week 12
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2
Time frame: Baseline up to Week 48
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3
Time frame: Baseline up to Week 48
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period
Time frame: Baseline (Day 1) up to 24 weeks (treatment period)
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period
Time frame: From end of treatment period up to Week 48 (follow-up period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25311593Dore GJ, Lawitz E, Hezode C, Shafran SD, Ramji A, Tatum HA, Taliani G, Tran A, Brunetto MR, Zaltron S, Strasser SI, Weis N, Ghesquiere W, Lee SS, Larrey D, Pol S, Harley H, George J, Fung SK, de Ledinghen V, Hagens P, McPhee F, Hernandez D, Cohen D, Cooney E, Noviello S, Hughes EA. Daclatasvir plus peginterferon and ribavirin is noninferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection. Gastroenterology. 2015 Feb;148(2):355-366.e1. doi: 10.1053/j.gastro.2014.10.007. Epub 2014 Oct 13.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
26 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daclatasvir, Pegylated interferon alfa-2a and Ribavirin in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 26 sites in 6 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 4 inclusion and 18 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 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Australia, Canada, France, United States, Italy and 1 more country. 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 14 Dec 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 Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2 (time frame: Follow-up Week 24). 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?
On the ClinicalTrials.gov record for NCT01257204, 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 14 Dec 2015.