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| ID | Type | Description | Link |
|---|---|---|---|
| DEB025A2207 | Other Identifier | Sponsor Code |
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Debio 025 (alisporivir) is an oral cyclophilin inhibitor with a new mechanism of action demonstrating potent anti-hepatitis C virus (HCV) activity in pre-clinical models and patients.
The current standard of care (SOC) in HCV patients consists of a combination of peg-IFN alpha and ribavirin. Treatment duration and ribavirin dose depend on the genotype treated. Only 40-50% of patients with genotype 1 achieve a sustained viral response (SVR). This study assesses whether Debio 025 administered in combination with peg-IFN alpha 2a and ribavirin can improve the outcome of treatment in this group of patients.
This is a multicentre, open-label, randomized, 5 arm parallel-group, multiple dose study in 50 chronic hepatitis C virus (HCV) genotype 1 non-responders to standard treatment with peg-IFN alpha (2a or 2b) and ribavirin. The entire study lasts a maximum of 96 weeks and consists of a 48- or 72-week treatment period (according to response). A follow-up visit to assess the sustained viral response (SVR) takes place 24 weeks after treatment cessation, i.e., at study Week 72 or 96, or earlier for discontinued study participants.
There were 2 parts in the treatment period. Part 1 lasted from Day 1 to Day 29 (Weeks 1 to 4); Part 2 lasted from Week 5 to Week 48 or 72.
During Part 1 of treatment (Weeks 1 to 4), participants are randomized to 1 of 5 treatment arms and receive 4 weeks of Debio 025 (alisporivir) monotherapy, Debio 025 combined with standard dose peg-IFNα2a, or 1 of 3 triple therapies combining different doses of Debio 025 with peg-IFNα2a and ribavirin at standard doses.
During Part 2 of treatment (Weeks 5 to 48 or 72), participants receive standard doses of peg-IFNα2a/ribavirin dual therapy for 44 or 68 weeks, depending on their response to treatment. At Week 12, participants who do not achieve ≥ 2 log10 decrease in HCV RNA are withdrawn and considered treatment failures. Participants who have undetectable HCV RNA levels and/or ≥ 2 log10 decrease in HCV RNA continue treatment until Week 24. At Week 24, participants who still have detectable HCV RNA levels are withdrawn and considered treatment failures. Participants with undetectable HCV RNA levels at Weeks 12 and 24 continue treatment until Week 48. At Week 24, "slow responders" (defined as participants with a detectable, but > 2 log10 decrease in HCV RNA levels at Week 12 and undetectable levels at Week 24) are eligible to continue treatment until Week 72.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm A | Experimental | Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response |
|
| Treatment Arm B | Experimental | Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response |
|
| Treatment Arm C | Experimental | Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response |
|
| Treatment Arm D | Experimental | Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Debio 025 | Drug | Debio 025 supplied as a 100 mg/mL oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Triple Therapy Treatment Arms (A, D, and E) | Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction. | Baseline to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Monotherapy and Dual Therapy Treatment Arms (B and C) | Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction. | Baseline to Day 29 |
| log10 Hepatitis C Virus RNA at Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raf Crabbé, MD | Debiopharm International S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic Liver Disease Research Center | La Jolla | California | 92037 | United States | ||
| University of Florida |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm A | Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 Weeks 1-4 |
|
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| Treatment Arm E | Experimental | Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response |
|
|
| Peg-IFNα2a | Drug | Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes |
|
|
| Ribavirin | Drug | Ribavirin supplied as 200 mg tablets |
|
|
Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction. |
| Day 29 |
| Percentage of Participants With a Rapid Viral Response at Day 29 | A participant had a rapid viral response if their viral RNA was undetectable (< 10 IU/mL). | Day 29 |
| Percentage of Participants With an Early Viral Response at Week 12 | A participant had an early viral response if their viral RNA had decreased ≥ 2 log10 at Week 12 compared to Baseline. | Baseline to Week 12 |
| Percentage of Participants With an End-of-treatment Response at the End of Treatment (Week 48 or 72) | A participant had an end-of-treatment response if their viral RNA was undetectable (< 10 IU/mL). | End of treatment (Week 48 or 72) |
| Percentage of Participants With a Sustained Viral Response 24 Weeks After the End of Treatment (Week 72 or 96) | A participant had a sustained viral response if their viral RNA was undetectable (< 10 IU/mL). | 24 weeks after the end of treatment (Week 72 or 96) |
| Gainesville |
| Florida |
| 32610 |
| United States |
| University of Miami Center for Liver Diseases | Miami | Florida | 33136 | United States |
| The Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | United States |
| Methodist Transplant Physicians | Dallas | Texas | 75203 | United States |
| Metropolitan Research | Fairfax | Virginia | 22031 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| FG001 | Treatment Arm B | Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| FG002 | Treatment Arm C | Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| FG003 | Treatment Arm D | Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| FG004 | Treatment Arm E | Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| COMPLETED |
|
| NOT COMPLETED |
|
| Part 2 Weeks 5-48 or 72 |
|
Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm A | Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| BG001 | Treatment Arm B | Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| BG002 | Treatment Arm C | Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| BG003 | Treatment Arm D | Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| BG004 | Treatment Arm E | Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| BG005 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Triple Therapy Treatment Arms (A, D, and E) | Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction. | Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment. | Posted | Mean | Standard Deviation | Log10(IU/mL) | Baseline to Day 29 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Monotherapy and Dual Therapy Treatment Arms (B and C) | Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction. | Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment. | Posted | Mean | Standard Deviation | Log10(IU/mL) | Baseline to Day 29 |
| |||||||||||||||||||||||||||||||||
| Secondary | log10 Hepatitis C Virus RNA at Day 29 | Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction. | Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment. | Posted | Mean | Standard Deviation | Log10(IU/mL) | Day 29 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Rapid Viral Response at Day 29 | A participant had a rapid viral response if their viral RNA was undetectable (< 10 IU/mL). | Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 29 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Early Viral Response at Week 12 | A participant had an early viral response if their viral RNA had decreased ≥ 2 log10 at Week 12 compared to Baseline. | Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment. | Posted | Number | percentage of participants | Baseline to Week 12 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an End-of-treatment Response at the End of Treatment (Week 48 or 72) | A participant had an end-of-treatment response if their viral RNA was undetectable (< 10 IU/mL). | Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment. | Posted | Number | percentage of participants | End of treatment (Week 48 or 72) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Sustained Viral Response 24 Weeks After the End of Treatment (Week 72 or 96) | A participant had a sustained viral response if their viral RNA was undetectable (< 10 IU/mL). | Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment. | Posted | Number | percentage of participants | 24 weeks after the end of treatment (Week 72 or 96) |
|
Within 72 weeks
Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
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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 | Treatment Arm A | Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets | 0 | 10 | 10 | 10 | ||
| EG001 | Treatment Arm B | Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets | 0 | 9 | 9 | 9 | ||
| EG002 | Treatment Arm C | Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets | 1 | 11 | 11 | 11 | ||
| EG003 | Treatment Arm D | Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets | 0 | 10 | 10 | 10 | ||
| EG004 | Treatment Arm E | Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets | 0 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Pyelonephritis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Aphthous Stomatitis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Chapped lips | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Faecal Volume Increased | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Faeces Pale | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hunger | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Salivary Hypersecretion | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Sensitivity of Teeth | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Early Satiety | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Injection Site Haematoma | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Injection Site Reaction | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dermatitis infected | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Nail bed infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Bacteria urine | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Blood Thyroid Stimulating Hormone Increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Blood Triglycerides Increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase Increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Mean cell volume increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Osteocalcin Increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Red blood cells urine | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Urine Output Increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Resorption Bone Increased | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Mental Impairment | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Parosmia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Psychomotor Hyperactivity | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Depressed Mood | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Memory impairment | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Glycosurea | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Menstruation Irregular | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dyspneoa | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nasal Dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pruritus Generalised | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Rash Macular | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Seborrhoeic Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Skin Odour Abnormal | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Venous insufficiency | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean-Maurice Dumont, Vice President Medical Affairs | Debiopharm International S.A. | 4121 321 01 11 | jean-maurice.dumont@debiopharm.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006505 | Hepatitis |
| 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 |
| D006521 | Hepatitis, Chronic |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C499715 | alisporivir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Units | Counts |
|---|---|
| Participants |
|
|
Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| OG003 | Treatment Arm D | Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| OG004 | Treatment Arm E | Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
|
|
Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| OG003 | Treatment Arm D | Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| OG004 | Treatment Arm E | Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
|
|
| Treatment Arm C |
Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| OG003 | Treatment Arm D | Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| OG004 | Treatment Arm E | Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
|
|
| Treatment Arm C |
Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| OG003 | Treatment Arm D | Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| OG004 | Treatment Arm E | Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
|
|
| OG002 |
| Treatment Arm C |
Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| OG003 | Treatment Arm D | Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
| OG004 | Treatment Arm E | Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response Debio 025: Debio 025 supplied as a 100 mg/mL oral solution Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes Ribavirin: Ribavirin supplied as 200 mg tablets |
|
|