Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TMC435HPC2002 | Other Identifier | Janssen R&D Ireland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the efficacy and safety of TMC435 plus PSI-7977 (GS7977) with or without ribavirin in patients who are chronically infected with genotype 1 hepatitis C virus (HCV) and who did not respond to prior peginterferon/ribavirin therapy or are HCV treatment-naive (patients who never received treatment for HCV infection).
This is a Phase IIa, randomized (the study medications are assigned by chance), open label (all people know the identity of the intervention) study of TMC435 plus PSI-7977 (GS7977) with or without ribavirin. The study consists of a screening phase (6 weeks); a treatment phase (12 or 24 week period); and a posttreatment phase (follow-up period up to Week 48). Approximately 180 patients will be enrolled in this study. Patients will be sequentially enrolled into two cohorts in this study. Cohort 1 (90 patients) will include patients without advanced hepatic fibrosis who did not respond to previous PegIFN/ribavirin therapy and Cohort 2 (90 patients) will include only patients with advanced hepatic fibrosis who did not respond to previous PegIFN/ribavirin therapy or are HCV treatment-naive. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. The entire study duration for each participant will be approximately 48 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 30 patients will receive TMC435 (150 mg once a day) plus PSI-7977(GS7977) (400 mg once a day) with ribavirin (1000-1200 mg/day) for 24 weeks and followed by a 24-week follow-up phase. |
|
| Arm 2 | Experimental | 15 patients wiil receive TMC435 (150 mg once a day) plus PSI-7977 (GS7977) (400 mg once a day) for 24 weeks of and followed by a 24-week follow-up phase. |
|
| Arm 3 | Experimental | 30 patients will receive TMC435 (150 mg once a day) plus PSI-7977 (GS7977) (400 mg once a day) with ribavirin (1000-1200 mg/day) for 12 weeks and followed by a 36-week follow-up phase. |
|
| Arm 4 | Experimental | 15 patients will receive TMC435 (150 mg once a day) plus PSI-7977 (GS7977) (400 mg once a day) for 12 weeks and followed by a 36-week follow-up phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMC435 | Drug | TMC435 will be administered as one oral capsule of 150 mg once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT) | Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the planned end of treatment. | Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT) | Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the planned end of treatment. | Week 12 and 16 (for the arms treated for 12 weeks) or Week 24 and 28 (for the arms treated for 24 weeks) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen R&D Ireland Clinical Trial | Janssen R&D Ireland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoover | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25078309 | Derived | Lawitz E, Sulkowski MS, Ghalib R, Rodriguez-Torres M, Younossi ZM, Corregidor A, DeJesus E, Pearlman B, Rabinovitz M, Gitlin N, Lim JK, Pockros PJ, Scott JD, Fevery B, Lambrecht T, Ouwerkerk-Mahadevan S, Callewaert K, Symonds WT, Picchio G, Lindsay KL, Beumont M, Jacobson IM. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet. 2014 Nov 15;384(9956):1756-65. doi: 10.1016/S0140-6736(14)61036-9. Epub 2014 Jul 28. |
Not provided
Not provided
A total of 168 participants enrolled to study. 1 participant who was randomized to Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks group, but never received treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks | Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PSI-7977 (GS7977) | Drug | PSI-7977 (GS7977) will be administered as oral tablets (2 tablets of 200 mg for Cohort 1 and 1 tablet of 400 mg for Cohort 2) once a day. |
|
|
| Ribavirin | Drug | Ribavirin will be administered according to body weight. For patients with body weight less than 75 kg daily dose (1000 mg) will be administered as 400 mg (2 oral tablets of 200 mg) in the morning and 600 mg (3 oral tablets of 200 mg) in the evening. Body weight more than or equal to 75 kg daily dose (1200 mg) will be administered as 600 mg twice a day (3 tablets of 200 mg per intake, morning and evening). |
|
| Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT) | Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at 24 weeks after the planned end of treatment. | Week 12 and 36 (for the arms treated for 12 weeks) or Week 24 and 48 (for the arms treated for 24 weeks) |
| Number of Participants With a Sustained Virologic Response (SVR) at Week 48 | Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at week 48. | Week 48 |
| Number of Participants With Viral Breakthrough | Viral breakthrough was defined as confirmed quantifiable HCV RNA after becoming less than (<) lower limit of quantification (LLOQ) or confirmed greater than (>) 1 log10 HCV RNA increase from the lowest level reached on 2 consecutive occasions. | Up to End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)] |
| Number of Participants With Inadequate Virologic Response | Inadequate Virologic Response was defined as confirmed detectable HCV RNA at or after Week 8 and not meeting the viral breakthrough definition. | Week 8 and End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)] |
| Number of Participants With Viral Relapse | Viral relapse was defined as undetectable HCV RNA at the actual EOT and confirmed quantifiable HCV RNA (>= 25 IU/mL) during follow-up period. | During the Follow-up [Week 36 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)] |
| Bakersfield |
| California |
| United States |
| La Jolla | California | United States |
| San Diego | California | United States |
| New Haven | Connecticut | United States |
| Brandenton | Florida | United States |
| Jacksonville | Florida | United States |
| Orlando | Florida | United States |
| Tampa | Florida | United States |
| Wellington | Florida | United States |
| Atlanta | Georgia | United States |
| Chicago | Illinois | United States |
| Lutherville | Maryland | United States |
| Lebanon | New Hampshire | United States |
| New York | New York | United States |
| Pittsburgh | Pennsylvania | United States |
| Arlington | Texas | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Falls Church | Virginia | United States |
| Norfolk | Virginia | United States |
| Seatle | Washington | United States |
| Santurce | Puerto Rico |
| FG001 | Cohort 1: TMC435 and PSI-7977 for 24 Weeks | Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| FG002 | Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks | Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| FG003 | Cohort 1: TMC435 and PSI-7977 for 12 Weeks | Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| FG004 | Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks | Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| FG005 | Cohort 2: TMC435 and PSI-7977 for 24 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| FG006 | Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| FG007 | Cohort 2: TMC435 and PSI-7977 for 12 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks | Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| BG001 | Cohort 1: TMC435 and PSI-7977 for 24 Weeks | Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| BG002 | Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks | Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| BG003 | Cohort 1: TMC435 and PSI-7977 for 12 Weeks | Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| BG004 | Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks | Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| BG005 | Cohort 2: TMC435 and PSI-7977 for 24 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| BG006 | Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| BG007 | Cohort 2: TMC435 and PSI-7977 for 12 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| BG008 | 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, Continuous | Median | Full Range | years |
| |||||||||||||||
| 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 | Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT) | Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the planned end of treatment. | Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug. | Posted | Number | Participants | Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks) |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT) | Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the planned end of treatment. | Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug. | Posted | Number | Participants | Week 12 and 16 (for the arms treated for 12 weeks) or Week 24 and 28 (for the arms treated for 24 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT) | Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at 24 weeks after the planned end of treatment. | Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug. | Posted | Number | Participants | Week 12 and 36 (for the arms treated for 12 weeks) or Week 24 and 48 (for the arms treated for 24 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Sustained Virologic Response (SVR) at Week 48 | Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at week 48. | Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug. | Posted | Number | Participants | Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Viral Breakthrough | Viral breakthrough was defined as confirmed quantifiable HCV RNA after becoming less than (<) lower limit of quantification (LLOQ) or confirmed greater than (>) 1 log10 HCV RNA increase from the lowest level reached on 2 consecutive occasions. | Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug. | Posted | Number | Participants | Up to End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)] |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Inadequate Virologic Response | Inadequate Virologic Response was defined as confirmed detectable HCV RNA at or after Week 8 and not meeting the viral breakthrough definition. | Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug. | Posted | Number | Participants | Week 8 and End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)] |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Viral Relapse | Viral relapse was defined as undetectable HCV RNA at the actual EOT and confirmed quantifiable HCV RNA (>= 25 IU/mL) during follow-up period. | Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug. | Posted | Number | Participants | During the Follow-up [Week 36 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)] |
|
Up to Week 48
Not provided
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 | Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks | Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase. | 3 | 54 | 48 | 54 | ||
| EG001 | Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks | Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase. | 1 | 31 | 25 | 31 | ||
| EG002 | Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks | Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. | 0 | 54 | 42 | 54 | ||
| EG003 | Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks | Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. | 0 | 28 | 17 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Blood amylase increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Leader | Janssen Research & Development, LLC | ClinicalTrialDisclosure@its.jnj.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 |
|---|---|
| D000069616 | Simeprevir |
| D000069474 | Sofosbuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
Not provided
Not provided
| Male |
|
| OG002 | Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks | Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG003 | Cohort 1: TMC435 and PSI-7977 for 12 Weeks | Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG004 | Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks | Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| OG005 | Cohort 2: TMC435 and PSI-7977 for 24 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| OG006 | Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG007 | Cohort 2: TMC435 and PSI-7977 for 12 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. |
|
|
| Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks |
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG003 | Cohort 1: TMC435 and PSI-7977 for 12 Weeks | Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG004 | Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks | Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| OG005 | Cohort 2: TMC435 and PSI-7977 for 24 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| OG006 | Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG007 | Cohort 2: TMC435 and PSI-7977 for 12 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. |
|
|
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
| OG003 | Cohort 1: TMC435 and PSI-7977 for 12 Weeks | Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG004 | Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks | Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| OG005 | Cohort 2: TMC435 and PSI-7977 for 24 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| OG006 | Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG007 | Cohort 2: TMC435 and PSI-7977 for 12 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. |
|
|
| Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks |
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG003 | Cohort 1: TMC435 and PSI-7977 for 12 Weeks | Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG004 | Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks | Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| OG005 | Cohort 2: TMC435 and PSI-7977 for 24 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| OG006 | Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG007 | Cohort 2: TMC435 and PSI-7977 for 12 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. |
|
|
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG003 | Cohort 1: TMC435 and PSI-7977 for 12 Weeks | Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG004 | Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks | Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| OG005 | Cohort 2: TMC435 and PSI-7977 for 24 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| OG006 | Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG007 | Cohort 2: TMC435 and PSI-7977 for 12 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. |
|
|
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG003 | Cohort 1: TMC435 and PSI-7977 for 12 Weeks | Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG004 | Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks | Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| OG005 | Cohort 2: TMC435 and PSI-7977 for 24 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase. |
| OG006 | Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. |
| OG007 | Cohort 2: TMC435 and PSI-7977 for 12 Weeks | Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. |
|
|