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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004331-12 | EudraCT Number |
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The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients with liver cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV) | Experimental | Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCV | Drug |
| ||
| SOF |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR12) | SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms | SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach. |
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For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Medical Center Of USC | Los Angeles | California | 90033 | United States | ||
| University Of California, San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30382942 | Derived | Poordad F, Shiffman ML, Ghesquiere W, Wong A, Huhn GD, Wong F, Ramji A, Shafran SD, McPhee F, Yang R, Noviello S, Linaberry M; ALLY-3C study team. Daclatasvir and sofosbuvir with ribavirin for 24 weeks in chronic hepatitis C genotype-3-infected patients with cirrhosis: a Phase III study (ALLY-3C). Antivir Ther. 2019;24(1):35-44. doi: 10.3851/IMP3278. |
| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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Of the 106 subjects enrolled, 78 participants entered the treatment period and received study treatment; 28 participants were enrolled but did not enter the treatment period. 26 were due to no longer meeting study criteria; 1 was due to poor/non-compliance (missed Day 1 visit); and 1 was other (missed screening window).
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Naive | HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs |
| FG001 | Treatment Experienced | HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2015 | Mar 1, 2018 |
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| RBV | Drug |
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| Week 12 (Follow-up period) |
| Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24 | HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria. SVR12 is based on Next Value Carried Backwards approach. | At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment (24 weeks), Follow Up Week 4 (28 weeks), Follow Up Week 12 (36 weeks), Follow Up Week 24 (48 weeks) |
| Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24 | HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria. | At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment, Follow Up Week 4, Follow Up Week 12, Follow Up Week 24 |
| San Francisco |
| California |
| 94143 |
| United States |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | United States |
| Ruth Rothstein Core Center | Chicago | Illinois | 60612 | United States |
| Digestive Disease Associates, PA | Catonsville | Maryland | 21228 | United States |
| Northeast Clinical Research Center | Bethlehem | Pennsylvania | 18017 | United States |
| University Gastroenterology | Providence | Rhode Island | 02905 | United States |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | United States |
| Methodist Transplant Physicians | Dallas | Texas | 75203 | United States |
| The Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Bon Secours St. Mary's Hospital of Richmond, Inc | Richmond | Virginia | 23226 | United States |
| Local Institution | Calgary | Alberta | T2N 4Z6 | Canada |
| Local Institution | Edmonton | Alberta | T6G 2P4 | Canada |
| Local Institution | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Local Institution | Victoria | British Columbia | V8V 3P9 | Canada |
| Local Institution | Toronto | Ontario | M5G 2C4 | Canada |
| Local Institution | Montreal | Quebec | H3T 1E2 | Canada |
| Local Institution | Regina | Saskatchewan | S4O 0W5 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| Follow Up Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Naive | HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs |
| BG001 | Treatment Experienced | HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All Treated Participants | Mean | Standard Deviation | Years |
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| Sex: Female, Male | All Treated Participants | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Sustained Virologic Response (SVR12) | SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach. | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms | SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach. | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 (Follow-up period) |
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| Secondary | Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24 | HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria. SVR12 is based on Next Value Carried Backwards approach. | All treated participants | Posted | Number | 95% Confidence Interval | Percentage | At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment (24 weeks), Follow Up Week 4 (28 weeks), Follow Up Week 12 (36 weeks), Follow Up Week 24 (48 weeks) |
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| Secondary | Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24 | HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria. | All treated participants | Posted | Number | 95% Confidence Interval | Percentage | At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment, Follow Up Week 4, Follow Up Week 12, Follow Up Week 24 |
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From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall: Daclatasvir(DCV) + Sofosbuvir(SOF) + Ribavirin(RBV) | Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks. | 0 | 78 | 8 | 78 | 63 | 78 |
| EG001 | HCV Treatment Naive | HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs | 0 | 54 | 4 | 54 | 44 | 54 |
| EG002 | HCV Treatment Experienced | HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents | 0 | 24 | 4 | 24 | 19 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Streptococcal bacteraemia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Oral Herpes | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pruritis Generalised | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email: | Clinical.Trials@bms.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 14, 2015 | Mar 1, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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