Chronic Hepatitis C InfectionPhase 3DIMENSIONNCT01866930
Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV
A Phase 3 study testing Pegylated Interferon Lambda-1a, Daclatasvir (DCV) and Ribasphere (RBV) in people with Chronic Hepatitis C Infection, run by Bristol-Myers Squibb at 63 sites in 12 countries.
Trial summary
To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C Infection
- What is being tested?
- Pegylated Interferon Lambda-1a, Daclatasvir (DCV) and Ribasphere (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
- 453 participants
- Where
- 63 sitesin 12 countries
- Study dates
- 11 Jul 2013to 27 Aug 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCV Genotype-1, -2, -3 or -4 treatment naïve;
- HCV RNA ≥10,000 IU/mL at screening;
- HIV-1 infection [(approximately 200 subjects receiving HAART, approximately 100 subjects not receiving highly active antiretroviral therapy (HAART)];
- For subjects receiving HAART, HIV RNA must be below <40 copies/mL at screening and <200 copies/mL for at least 8 weeks prior to screening;
- CD4 cell count at screening must be ≥100 cells/μL if receiving HAART or ≥350 cells/μL if not receiving HAART)
- Seronegative for Hepatitis B Surface Antigen (HBsAg)
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- Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive. BMI=weight (kg)/[height (m)]2 at screening;
- Subjects with compensated cirrhosis are permitted, but the number of subjects will be capped at approximately 30%. If a subject does not have cirrhosis, a liver biopsy within 3 years prior to enrollment is required to demonstrate the absence of cirrhosis. If cirrhosis is present, any prior liver biopsy is sufficient. Fibroscan® or FibroTest are acceptable if performed within 1 year prior to treatment in countries where liver biopsy is not required prior to treatment and where non-invasive imaging tests are approved for staging of liver disease
- Subjects with mild to moderate hemophilia as defined as:
- Mild-factor level activity of 6-4% OR
- Moderate defined as factor level activity of 1-5%
Who cannot join
- Any evidence of liver disease other than chronic HCV;
- Subjects infected with human immunodeficiency virus (HIV-2);
- Diagnosed or suspected hepatocellular carcinoma;
- Decompensated liver disease;
- Presence of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 weeks prior to study entry (AIDS-defining opportunistic infections as defined by the CDC, (CDC, JAMA 1993 Feb 10;269(6):729-30)
- Laboratory values: ANC <1.5 x 109 cells/L (<1.2 x 109 cells/L for Blacks), platelet count <90 x 109 cells/L, hemoglobin <11 g/dL for females, hemoglobin <12 g/dL for males;
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- Subjects (receiving HAART) who had first initiated anti-retroviral therapy within last 8 weeks prior to Day 1; however, if changes are required to a subject's HAART regimen to meet the requirements of the protocol, these changes are allowed at the screening visit. Subjects should wait a minimum of 1 month prior to Day 1 after a repeat of HIV viral load has been confirmed, <40 copies/mL
- Subjects on Zidovudine (AZT), Didanosine (ddI), or Stavudine (d4T);
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Subjects with severe hemophilia (defined as <1% factor activity level)
Trial locations and contacts
63 sites in 12 countries.
63 sites in 12 countries
United States13 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18102
Emory Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, 30308
Emory University
Atlanta, Georgia, 30308
University Of Colorado Denver & Hospital
Aurora, Colorado, 80045
University Of Colorado Denver
Aurora, Colorado, 80045
Mercy Medical Center
Baltimore, Maryland, 21202
Ut Southwestern Medical Center
Dallas, Texas, 75235
Duke Clinical Research Institute
Durham, North Carolina, 27710
Yale University
New Haven, Connecticut, 06510
Orlando Va Medical Center
Orlando, Florida, 32803
Inland Empire Liver Foundation
Rialto, California, 92377
University Of California San Francisco
San Francisco, California, 94110
Kaiser Permanente Medical Center
San Francisco, California, 94118
Canada7 sites
University Of Alberta Hospitals
Edmonton, Alberta, T6G 2B7
Hamilton Health Sciences, Mcmaster Site
Hamilton, Ontario, L8V 1C3
Mcgill University Health Centre (Muhc) Montreal Chest Institute
Montreal, Quebec, H2X 2P4
Ottawa Hospital General Campus
Ottawa, Ontario, K1H 8L6
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
St Pauls Hospital
Vancouver, British Columbia, V6Z 1Y6
Vancouver Id Reserach & Care Centre Society
Vancouver, British Columbia, V6Z 2C7
Argentina5 sites
Local Institution
Buenos Aires, 1119
Local Institution
Buenos Aires, 1202
Local Institution
Buenos Aires, Bs As, Buenos Aires, 1141
Local Institution
Mar del Plata, Buenos Aires, 7600
Local Institution
Quilmes, Buenos Aires, 1878
France5 sites
Local Institution
Le Kremlin-Bicêtre, 94275
Local Institution
Lyon, 69317
Local Institution
Paris, 75010
Local Institution
Paris, 75020
Local Institution
Pessac, 33604
Italy5 sites
Local Institution
Antella (fi), 50011
Local Institution
Brescia, 25123
Local Institution
Milan, 20127
Local Institution
Monza, 20052
Local Institution
Roma, 00149
Russia5 sites
Local Institution
Moscow, 105275
Local Institution
Moscow, 111123
Local Institution
Saint Petersburg, 190103
Local Institution
Saint Petersburg, 196645
Local Institution
Volgograd, 400040
Spain5 sites
Local Institution
Barcelona, 08029
Local Institution
Cartagena (Murcia), 30202
Local Institution
Donosti-San Sebastian, 20014
Local Institution
Madrid, 28034
Local Institution
Madrid, 28041
United Kingdom5 sites
Local Institution
Brighton, BN2 5BE
Local Institution
London, Greater London, SW10 9TH
Local Institution
London, E11BB
Local Institution
London, NW3 2QG
Local Institution
London, W2 1NY
Germany4 sites
Local Institution
Berlin, 13353
Local Institution
Bonn, 53105
Local Institution
Bonn, 53127
Local Institution
Hamburg, 20146
Mexico4 sites
Local Institution
Ciudad Juárez, Chihuahua, 35350
Local Institution
Guadalajara, Jalisco, 44280
Local Institution
León, Guanajuato, 37320
Local Institution
Mexico City, Mexico City, 14080
Belgium3 sites
Local Institution
Antwerp, 2000
Local Institution
Brussels, 1000
Local Institution
Brussels, 1200
About this study
Official title: Phase 3 Open Label Study Evaluating the Efficacy and Safety of Pegylated Interferon Lambda-1a, in Combination With Ribavirin and Daclatasvir, for Treatment of Chronic HCV Infection With Treatment naïve Genotypes 1, 2, 3 or 4 in Subjects Co-infected With HIV
To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1
Read the detailed description
Study Classification: Safety/Efficacy and Pharmacokinetics/dynamics
GT=genotype
- Conditions
- Chronic Hepatitis C Infection
- Being tested
- Pegylated Interferon Lambda-1a, Daclatasvir (DCV), Ribasphere (RBV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Interferon Lambda-1aBiological
Also called BMS-914143
Daclatasvir (DCV)Drug
Also called BMS-790052
Ribasphere (RBV)Drug
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: GT-2 or -3 HCV Treatment Naïve Subjects | Experimental | Pegylated Interferon Lambda 180 µg solution, injection subcutaneously once weekly for 24 weeks
Ribasphere 200 mg tablets (800 mg per day: two 200 mg tablets in the morning and two 200 mg tablets in the evening) by mouth twice daily for 24 weeks
Daclatasvir 30 mg, 60 mg, or 90 mg tablets (depending on concomitant HIV regimen) once daily for 12 weeks Receives: Biological: Pegylated Interferon Lambda-1a; Drug: Daclatasvir (DCV); Drug: Ribasphere (RBV) |
| Cohort B: GT-1 or -4 HCV Treatment Naïve Subjects | Experimental | Pegylated Interferon Lambda 180 µg solution, injection subcutaneously once weekly for 24 or 48 weeks
Ribasphere 200 mg tablets, (1000 mg per day: two 200 mg tablets in the morning and three 200 mg tablets in the evening for subjects weighing <75 kg and 1200 mg per day: three 200 mg tablets in morning and three 200 mg tablets in evening for subjects weighing ≥75 kg) by mouth twice daily for 24 or 48 weeks
Daclatasvir 30 mg, 60 mg, or 90 mg tablets (depending on concomitant HIV regimen) once daily for 12 weeks Receives: Biological: Pegylated Interferon Lambda-1a; Drug: Daclatasvir (DCV); Drug: Ribasphere (RBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)
SVR12 was defined as HCV RNA less than lower limit of quantification (< LLOQ) (25 IU/mL; target detected or not detected) at follow-up week 12.
Measured: Follow-up week 12
Secondary outcomes (12)
Number of Participants With Rapid Virologic Response (RVR) and Extended Rapid Virologic Response (eRVR)
RVR is defined as HCV RNA < LLOQ target not detected at Week 4 and eRVR defined as HCV RNA < LLOQ target not detected at Weeks 4 and 12
Measured: Treatment weeks 4 and 12
Number of Subjects With Sustained Virologic Response at Post-treatment Week 24 (SVR24)
SVR24 was defined as HCV RNA < LLOQ (25 IU/mL; target detected or not detected) at 24 weeks post treatment.
Measured: Follow-up week 24
Number of Participants With Treatment Emergent Cytopenic Abnormalities
All treated participants were monitored for treatment emergent cytopenic abnormalities (anemia as defined by hemoglobin (Hb) < 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) < 750 mm3 and/or thrombocytopenia as defined by platelets < 50,000/mm3) during the treatment period (Weeks 1, 2, 4, 6, 8, 12, 20, and 24, and at Weeks 28, 32, 36, 40, 44, and 48 for subjects requiring those visits).
Measured: After Day 1 to end of treatment; up to Weeks 24 or 48
Number of Participants With On-treatment IFN-associated Flu-like or Musculoskeletal Symptoms
All treated participants were monitored for IFN-associated Flu-like and Musculoskeletal symptoms. Flu-like symptoms were defined as pyrexia, chills, or pain. Musculoskeletal symptoms were defined as arthralgia, myalgia, or back pain. Subjects were monitored throughout the treatment period during the treatment period (After day 1 up to week 24, or After day 1 up to week 48 for subjects requiring those visits).
Measured: After Day 1 to end of treatment; up to Weeks 24 or 48
Number of Participants Who Died or Experienced Severe Adverse Events (SAEs), Dose Reductions of Lambda or Discontinuation Due to Adverse Events (AEs)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that. at any dose, results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.
Measured: After Day 1 to end of treatment; up to Weeks 24 or 48
Number of Participants With Treatment-emergent Grade 3/4 Lab Abnormalities
Grade 3/4 treatment-emergent lab abnormalities that occurred in >=5% of subjects in either cohort are reported. The analysis included all treated subjects up to the end of the treatment period (Day 1 to week 24, or Day 1 to week 48 for subjects requiring those visits). Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AST = Aspartate aminotransferase, ALT = Alanine aminotransferase.
Measured: After Day 1 to end of treatment; up to Weeks 24 or 48
Mean Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment
All treated participants were monitored for change in Absolute CD4 T Lymphocyte count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants is reported in Cells/µL.
Measured: Day 1 to end of treatment; up to week 24 or week 48
Mean Percent Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment
All treated participants were monitored for percent change in CD4 T Lymphocyte count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants.
Measured: Day 1 to end of treatment; up to week 24 or week 48
Mean Change in Total Lymphocyte Count From Baseline to End of Treatment
All treated participants were monitored for change in Total Lymphocyte Count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants is reported in Cells/µL.
Measured: Day 1 to end of treatment; up to week 24 or week 48
Mean Percent Change in Total Lymphocyte Count From Baseline to End of Treatment
All treated participants were monitored for percent change in Total Lymphocyte Count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants.
Measured: Day 1 to end of treatment; up to week 24 or week 48
Mean Change in Platelet Count From Baseline to End of Treatment
All treated participants were monitored for change in Platelet Count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants (units of measurement = x10^9 cells/L).
Measured: Day 1 to end of treatment; up to week 24 or week 48
Mean Percent Change in Platelet Count From Baseline to End of Treatment
All treated participants were monitored for percent change in Platelet Count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants.
Measured: Day 1 to end of treatment; up to week 24 or week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2013 (estimated)
- Study start11 Jul 2013
- Primary completion27 Aug 2015
- Study completion27 Aug 2015
Why it stopped: Sponsor decision not based on any new unexpected safety findings or efficacy observations.
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 Chronic Hepatitis C InfectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 453 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
- NCT01866930
- Sponsor's protocol ID
- AI452-032
- Other IDs
- 2012-003280-22
- Acronym
- DIMENSION
- Status last verified
- Feb 2023
- First submitted
- 29 May 2013
- Last updated
- 13 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nelson M, Rubio R, Lazzarin A, Romanova S, Luetkemeyer A, Conway B, Molina JM, Xu D, Srinivasan S, Portsmouth S. Safety and Efficacy of Pegylated Interferon Lambda, Ribavirin, and Daclatasvir in HCV and HIV-Coinfected Patients. J Interferon Cytokine Res. 2017 Mar;37(3):103-111. doi: 10.1089/jir.2016.0082. Epub 2017 Feb 17.
PubMed 28282271
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Open Label Study Evaluating the Efficacy and Safety of Pegylated Interferon Lambda-1a, in Combination With Ribavirin and Daclatasvir, for Treatment of Chronic HCV Infection With Treatment naïve Genotypes 1, 2, 3 or 4 in Subjects Co-infected With HIV
- ClinicalTrials.gov ID
- NCT01866930
- Acronym / sponsor ID
- DIMENSION / AI452-032
- Conditions
- Chronic Hepatitis C Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision not based on any new unexpected safety findings or efficacy observations.
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2013 (actual)
- Primary completion
- 27 Aug 2015 (actual)
- Study completion
- 27 Aug 2015 (actual)
- First posted
- 3 Jun 2013 (estimated)
- Results
- Posted 13 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1
Detailed description
Study Classification: Safety/Efficacy and Pharmacokinetics/dynamics
GT=genotype
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: GT-2 or -3 HCV Treatment Naïve Subjects | Experimental | Biological: Pegylated Interferon Lambda-1a, Drug: Daclatasvir (DCV), Drug: Ribasphere (RBV)Pegylated Interferon Lambda 180 µg solution, injection subcutaneously once weekly for 24 weeks Ribasphere 200 mg tablets (800 mg per day: two 200 mg tablets in the morning and two 200 mg tablets in the evening) by mouth twice daily for 24 weeks Daclatasvir 30 mg, 60 mg, or 90 mg tablets (depending on concomitant HIV regimen) once daily for 12 weeks |
| Cohort B: GT-1 or -4 HCV Treatment Naïve Subjects | Experimental | Biological: Pegylated Interferon Lambda-1a, Drug: Daclatasvir (DCV), Drug: Ribasphere (RBV)Pegylated Interferon Lambda 180 µg solution, injection subcutaneously once weekly for 24 or 48 weeks Ribasphere 200 mg tablets, (1000 mg per day: two 200 mg tablets in the morning and three 200 mg tablets in the evening for subjects weighing <75 kg and 1200 mg per day: three 200 mg tablets in morning and three 200 mg tablets in evening for subjects weighing ≥75 kg) by mouth twice daily for 24 or 48 weeks Daclatasvir 30 mg, 60 mg, or 90 mg tablets (depending on concomitant HIV regimen) once daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- HCV Genotype-1, -2, -3 or -4 treatment naïve;
- HCV RNA ≥10,000 IU/mL at screening;
- HIV-1 infection [(approximately 200 subjects receiving HAART, approximately 100 subjects not receiving highly active antiretroviral therapy (HAART)];
- For subjects receiving HAART, HIV RNA must be below <40 copies/mL at screening and <200 copies/mL for at least 8 weeks prior to screening;
- CD4 cell count at screening must be ≥100 cells/μL if receiving HAART or ≥350 cells/μL if not receiving HAART)
Key exclusion criteria (10 listed)
- Any evidence of liver disease other than chronic HCV;
- Subjects infected with human immunodeficiency virus (HIV-2);
- Diagnosed or suspected hepatocellular carcinoma;
- Decompensated liver disease;
- Presence of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 weeks prior to study entry (AIDS-defining opportunistic infections as defined by the CDC, (CDC, JAMA 1993 Feb 10;269(6):729-30)
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 |
|---|---|---|
| Pegylated Interferon Lambda-1aAlso: BMS-914143 | Biological | Cohort A: GT-2 or -3 HCV Treatment Naïve Subjects, Cohort B: GT-1 or -4 HCV Treatment Naïve Subjects |
| Daclatasvir (DCV)Also: BMS-790052 | Drug | Cohort A: GT-2 or -3 HCV Treatment Naïve Subjects, Cohort B: GT-1 or -4 HCV Treatment Naïve Subjects |
| Ribasphere (RBV) | Drug | Cohort A: GT-2 or -3 HCV Treatment Naïve Subjects, Cohort B: GT-1 or -4 HCV Treatment Naïve Subjects |
Primary outcome
Number of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)
Time frame: Follow-up week 12
SVR12 was defined as HCV RNA less than lower limit of quantification (< LLOQ) (25 IU/mL; target detected or not detected) at follow-up week 12.
12 secondary outcomes
Number of Participants With Rapid Virologic Response (RVR) and Extended Rapid Virologic Response (eRVR)
Time frame: Treatment weeks 4 and 12
Number of Subjects With Sustained Virologic Response at Post-treatment Week 24 (SVR24)
Time frame: Follow-up week 24
Number of Participants With Treatment Emergent Cytopenic Abnormalities
Time frame: After Day 1 to end of treatment; up to Weeks 24 or 48
Number of Participants With On-treatment IFN-associated Flu-like or Musculoskeletal Symptoms
Time frame: After Day 1 to end of treatment; up to Weeks 24 or 48
Number of Participants Who Died or Experienced Severe Adverse Events (SAEs), Dose Reductions of Lambda or Discontinuation Due to Adverse Events (AEs)
Time frame: After Day 1 to end of treatment; up to Weeks 24 or 48
Number of Participants With Treatment-emergent Grade 3/4 Lab Abnormalities
Time frame: After Day 1 to end of treatment; up to Weeks 24 or 48
Mean Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment
Time frame: Day 1 to end of treatment; up to week 24 or week 48
Mean Percent Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment
Time frame: Day 1 to end of treatment; up to week 24 or week 48
Mean Change in Total Lymphocyte Count From Baseline to End of Treatment
Time frame: Day 1 to end of treatment; up to week 24 or week 48
Mean Percent Change in Total Lymphocyte Count From Baseline to End of Treatment
Time frame: Day 1 to end of treatment; up to week 24 or week 48
Mean Change in Platelet Count From Baseline to End of Treatment
Time frame: Day 1 to end of treatment; up to week 24 or week 48
Mean Percent Change in Platelet Count From Baseline to End of Treatment
Time frame: Day 1 to end of treatment; up to week 24 or week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28282271Nelson M, Rubio R, Lazzarin A, Romanova S, Luetkemeyer A, Conway B, Molina JM, Xu D, Srinivasan S, Portsmouth S. Safety and Efficacy of Pegylated Interferon Lambda, Ribavirin, and Daclatasvir in HCV and HIV-Coinfected Patients. J Interferon Cytokine Res. 2017 Mar;37(3):103-111. doi: 10.1089/jir.2016.0082. Epub 2017 Feb 17.
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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
63 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegylated Interferon Lambda-1a, Daclatasvir (DCV) and Ribasphere (RBV) in people with Chronic Hepatitis C Infection, run by Bristol-Myers Squibb at 63 sites in 12 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 11 inclusion and 10 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: stopped early, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Canada, Argentina, France, Italy and 7 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 13 Jun 2023). 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?
Number of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) (time frame: Follow-up week 12). 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 NCT01866930, 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 13 Jun 2023.