Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000836-27 | EudraCT Number |
Not provided
Not provided
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Not provided
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The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.
Intervention Model:
Peginterferon alfa-2a
Ribavirin
Daclatasvir
Asunaprevir
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin | Experimental | Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks |
|
| Daclatasvir + PegIFNα-2a + Ribavirin | Experimental | Patients received daclatasvir, (two 30-mg tablets or one 60-mg tablet, by mouth once daily) + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks |
|
| Daclatasvir + Asunaprevir | Experimental | Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV) | SVR12 defined as HCV RNA\ | Week 12 (Follow-up period) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (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. | Week 12 (Follow-up period) |
| Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Medical Center South | Montgomery | Alabama | 36116 | United States | ||
| Scripps Clinic |
A total of 276 participants were enrolled, 228 were randomized and 227 received treatment. Participants were not treated because they no longer met study criteria (n=41), withdrew their consent (n=4), showed poor/non-compliance (n=1) or were lost to follow-up (n=2). One participant was randomized by mistake but received no treatment.
The study was conducted at 92 centers in 20 countries.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Daclatasvir + Asunaprevir | Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks |
| FG001 | Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Asunaprevir | Drug |
|
|
| Pegylated interferon alfa-2a | Drug |
|
|
| Ribavirin | Drug |
|
|
RVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 4. |
| Week 4 |
| Percentage of Participants With Extended Rapid Virologic Response (eRVR) | eRVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at both weeks 4 and 12. | Week 4 and 12 |
| Percentage of Participants With Complete Early Virologic Response (cEVR) | cEVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at week 12. | Week 12 |
| Percentage of Participants With End of the Treatment Response (EOTR) | EOTR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at end of treatment. | End of the study (Week 24) |
| Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) | SVR24 was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24. | Week 24 (Follow-up) |
| Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have 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. | For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation |
| La Jolla |
| California |
| 92037 |
| United States |
| Scpmg/ Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
| University Of Colorado Denver And Hospital | Aurora | Colorado | 80045 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06520 | United States |
| Uf Hepatology Research At Ctrb | Gainesville | Florida | 32610 | United States |
| Schiff Center For Liver Diseases | Miami | Florida | 33136 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Digestive Disease Associates, P.A. | Catonsville | Maryland | 21228 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | United States |
| North Shore Long Island Jewish Health System | Manhasset | New York | 11030 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Options Health Research, Llc | Tulsa | Oklahoma | 74104 | United States |
| University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Nashville Medical Research Institute | Nashville | Tennessee | 37205 | United States |
| Baylor College Of Medicine | Houston | Texas | 77030 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Metropolitan Research | Fairfax | Virginia | 22031 | United States |
| Dean Clinic | Madison | Wisconsin | 53715 | United States |
| Local Institution | Buenos Aires | Buenos Aires | 1119 | Argentina |
| Local Institution | Ciudad de Buenos Aires | Buenos Aires | C1121ABE | Argentina |
| Local Institution | Ciudad de Buenos Aires | Buenos Aires | C1181ACH | Argentina |
| Local Institution | Prov. Buenos Aires | Buenos Aires | 1629 | Argentina |
| Local Institution | Prov de Santa Fe | Santa Fe Province | 2000 | Argentina |
| Local Institution | Darlinghurst | New South Wales | 2010 | Australia |
| Local Institution | Kogarah | New South Wales | 2218 | Australia |
| Local Institution | Westmead Nsw | New South Wales | 2145 | Australia |
| Local Institution | Adelaide | South Australia | 5000 | Australia |
| Local Institution | Clayton Vic | Victoria | 3168 | Australia |
| Local Institution | Fitzroy | Victoria | 3065 VIC | Australia |
| Local Institution | Heidelberg | Victoria | 3084 | Australia |
| Local Institution | Melbourne | Victoria | 3004 | Australia |
| Local Institution | Fremantle | Western Australia | 6160 | Australia |
| Local Institution | Perth | Western Australia | 6001 | Australia |
| Local Institution | Graz | 8036 | Austria |
| Local Institution | Vienna | 1090 | Austria |
| Local Institution | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Local Institution | Victoria | British Columbia | V8V 3P9 | Canada |
| Local Institution | Toronto | Ontario | M5G 2N2 | Canada |
| Local Institution | Toronto | Ontario | M5T 2S8 | Canada |
| Local Institution | Toronto | Ontario | M6H 3M1 | Canada |
| Local Institution | Vaughan | Ontario | L4L 4Y7 | Canada |
| Local Institution | Montreal | Quebec | H2L 4P9 | Canada |
| Local Institution | Montreal | Quebec | H3T 1E2 | Canada |
| Local Institution | Québec | Quebec | G3K 2P8 | Canada |
| Local Institution | Hvidovre | 2650 | Denmark |
| Local Institution | Bondy | 93143 | France |
| Local Institution | Clichy | 92118 | France |
| Local Institution | Créteil | 94000 | France |
| Local Institution | Créteil | 94010 | France |
| Local Institution | Lille | 59037 | France |
| Local Institution | Lyon | 69288 | France |
| Local Institution | Marseille | 13285 | France |
| Local Institution | Montpellier | 34295 | France |
| Local Institution | Nice | 06202 | France |
| Local Institution | Paris | 75571 | France |
| Local Institution | Paris | 75651 | France |
| Local Institution | Paris | 75679 | France |
| Local Institution | Toulouse | 31059 | France |
| Local Institution | Vandœuvre-lès-Nancy | 54511 | France |
| Local Institution | Villejuif | 94804 | France |
| Local Institution | Berlin | 12157 | Germany |
| Local Institution | Berlin | 13353 | Germany |
| Local Institution | Bonn | 53105 | Germany |
| Local Institution | Frankfurt | 60590 | Germany |
| Local Institution | Hamburg | 20246 | Germany |
| Local Institution | Hanover | 30625 | Germany |
| Local Institution | Heidelberg | 69120 | Germany |
| Local Institution | Thesaloniki | 54639 | Greece |
| Local Institution | Dublin | Dublin | DUBLIN 7 | Ireland |
| Local Institution | Dublin | Dublin | Ireland |
| Local Institution | Brescia | 25123 | Italy |
| Local Institution | Cisanello (pisa) | 56124 | Italy |
| Local Institution | Messina | 98124 | Italy |
| Local Institution | Milan | 20121 | Italy |
| Local Institution | Pavia | 27100 | Italy |
| Local Institution | Roma | 00149 | Italy |
| Local Institution | Roma | 00161 | Italy |
| Local Institution | Torino | 10126 | Italy |
| Local Institution | Viale Del Policlinico, 155 | 00161 | Italy |
| Local Institution | Guadalajara | Jalisco | 44160 | Mexico |
| Local Institution | Auckland | 92024 | New Zealand |
| Local Institution | Bialystok | 15-540 | Poland |
| Local Institution | Wroclaw | 50-349 | Poland |
| Local Institution | Busan | 602-715 | South Korea |
| Local Institution | Busan | 602-739 | South Korea |
| Local Institution | Busan | 614-735 | South Korea |
| Local Institution | Daegu | 700-721 | South Korea |
| Local Institution | Daegu | 705-703 | South Korea |
| Local Institution | Gyeonggi-do | 420-767 | South Korea |
| Local Institution | Seoul | 120-752 | South Korea |
| Local Institution | Seoul | 138-736 | South Korea |
| Local Institution | Barcelona | 08036 | Spain |
| Local Institution | Gothenburg | SE-416 85 | Sweden |
| Local Institution | Stockholm | 141 86 | Sweden |
| Local Institution | Taichung | 402 | Taiwan |
| Local Institution | Taichung | 40447 | Taiwan |
| Local Institution | Taipei | 100 | Taiwan |
| Local Institution | Taipei | 112 | Taiwan |
| Local Institution | London | Greater London | NW3 2QG, | United Kingdom |
| Local Institution | London | Greater London | SE5 9RS | United Kingdom |
| Local Institution | London | Greater London | SW17 0QT | United Kingdom |
| Local Institution | London | Greater London | W2 1NY | United Kingdom |
| Local Institution | Manchester | Greater Manchester | M8 5RB | United Kingdom |
| Local Institution | Glasgow | Lanarkshire | G12 0YN | United Kingdom |
Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
| FG002 | Daclatasvir + pegIFN-2a+ Ribavirin | Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received at least 1 dose of study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Daclatasvir + Asunaprevir | Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks |
| BG001 | Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin | Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks |
| BG002 | Daclatasvir + pegIFN-2a+ Ribavirin | Patients received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV) | SVR12 defined as HCV RNA\ | Participants with genotype 1 HCV who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 (Follow-up period) |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (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. | The analysis was performed in all treated participants who did not exhibit Genotype 1. One subject with indeterminate genotype in the Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Arm/Group was excluded from the analysis | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 (Follow-up period) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4 | RVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 4. | The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy. | Posted | Number | Percentage of participants | Week 4 |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | eRVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at both weeks 4 and 12. | The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy. | Posted | Number | Percentage of participants | Week 4 and 12 |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Early Virologic Response (cEVR) | cEVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at week 12. | The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy. | Posted | Number | Percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With End of the Treatment Response (EOTR) | EOTR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at end of treatment. | The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy. | Posted | Number | Percentage of participants | End of the study (Week 24) |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) | SVR24 was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24. | The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy. | Posted | Number | Percentage of participants | Week 24 (Follow-up) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have 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. | The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy. | Posted | Number | Participants | For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation |
|
For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks).
On treatment period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daclatasvir + Asunaprevir | Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks. | 4 | 99 | 58 | 99 | ||
| EG001 | Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin | Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. | 3 | 122 | 118 | 122 | ||
| EG002 | Daclatasvir + pegIFN-2a+ Ribavirin | Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks | 0 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neuroendocrine carcinoma of the skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Viral rhinitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ocular icterus | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
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 | Clinical.Trials@bms.com |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C549273 | daclatasvir |
| C571889 | asunaprevir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| 65 years and older |
|
| Male |
|
Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
| OG003 | DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) | Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG004 | DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) | Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG005 | DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) | Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG006 | DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) | HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks. |
| OG007 | DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) | pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week. |
| OG008 | DCV + pegIFN-2a+ RBV | Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
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| OG003 | DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) | Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG004 | DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) | Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG005 | DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) | Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG006 | DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) | HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks. |
| OG007 | DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) | pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week. |
| OG008 | DCV + pegIFN-2a+ RBV | Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
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| OG003 | DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) | Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG004 | DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) | Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG005 | DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) | Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG006 | DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) | HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks. |
| OG007 | DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) | pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week. |
| OG008 | DCV + pegIFN-2a+ RBV | Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
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| OG003 | DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) | Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG004 | DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) | Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG005 | DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) | Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG006 | DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) | HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks. |
| OG007 | DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) | pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week. |
| OG008 | DCV + pegIFN-2a+ RBV | Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
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| OG003 | DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) | Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG004 | DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) | Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG005 | DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) | Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG006 | DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) | HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks. |
| OG007 | DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) | pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week. |
| OG008 | DCV + pegIFN-2a+ RBV | Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
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| OG003 | DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) | Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG004 | DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) | Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG005 | DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) | Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG006 | DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) | HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks. |
| OG007 | DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) | pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week. |
| OG008 | DCV + pegIFN-2a+ RBV | Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
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| OG002 |
| DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) |
Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG003 | DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) | Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG004 | DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) | Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG005 | DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) | Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
| OG006 | DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) | HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks. |
| OG007 | DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) | pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week. |
| OG008 | DCV + pegIFN-2a+ RBV | Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks. |
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