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Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants

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ClinicalTrials.gov Identifier: NCT01318694
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : September 30, 2016
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Alisporivir
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Drug: ALV Placebo
Enrollment 1081
Recruitment Details Of the 1580 patients screened at multiple global sites, 1081 (68.4%) were randomized and 499 (31.6%) discontinued from the study prior to randomization.
Pre-assignment Details Due to mis-randomization, four patients did not have a baseline visit and never started study medications. They were included in screened and randomized, but excluded from the Full Analysis Set and the Safety Set.
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Hide Arm/Group Description Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT) Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT) Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks ALV Placebo with PEG and RBV for 48 weeks
Period Title: Overall Study
Started 275 270 268 268
Full Analysis Set 274 270 265 268
Safety Set 273 268 265 265
Completed 223 212 225 200
Not Completed 52 58 43 68
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D Total
Hide Arm/Group Description Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks ALV Placebo with PEG and RBV for 48 weeks Total of all reporting groups
Overall Number of Baseline Participants 274 270 265 268 1077
Hide Baseline Analysis Population Description
Full Analysis Set (FAS), defined as all participants to whom study treatment was correctly assigned.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 274 participants 270 participants 265 participants 268 participants 1077 participants
45.9  (11.08) 45.8  (11.95) 45.5  (12.15) 46.3  (11.53) 45.9  (11.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants 270 participants 265 participants 268 participants 1077 participants
Female
113
  41.2%
106
  39.3%
134
  50.6%
114
  42.5%
467
  43.4%
Male
161
  58.8%
164
  60.7%
131
  49.4%
154
  57.5%
610
  56.6%
1.Primary Outcome
Title Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)
Hide Description SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment.
Time Frame 12 weeks after the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Hide Arm/Group Description:
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
ALV Placebo with PEG and RBV for 48 weeks
Overall Number of Participants Analyzed 274 270 265 268
Measure Type: Number
Unit of Measure: percentage of participants
68.6 68.9 69.4 52.5
2.Secondary Outcome
Title Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)
Hide Description SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.
Time Frame 24 weeks after the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Hide Arm/Group Description:
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
ALV Placebo with PEG and RBV for 48 weeks
Overall Number of Participants Analyzed 273 268 265 265
Measure Type: Number
Unit of Measure: percentage of participants
68.5 69.0 68.3 51.7
3.Secondary Outcome
Title Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)
Hide Description RVR4 was defined as serum HCV RNA < LOQ after 4 weeks of treatment.
Time Frame after 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Hide Arm/Group Description:
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
ALV Placebo with PEG and RBV for 48 weeks
Overall Number of Participants Analyzed 268 258 258 261
Measure Type: Number
Unit of Measure: percentage of participants
60.1 72.5 56.6 28.4
4.Secondary Outcome
Title Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment
Hide Description EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA < LOQ after 12 weeks of treatment.
Time Frame after 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Hide Arm/Group Description:
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
ALV Placebo with PEG and RBV for 48 weeks
Overall Number of Participants Analyzed 259 242 247 256
Measure Type: Number
Unit of Measure: percentage of participants
97.7 98.3 99.6 89.8
5.Secondary Outcome
Title Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment
Hide Description pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment.
Time Frame after 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Hide Arm/Group Description:
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
ALV Placebo with PEG and RBV for 48 weeks
Overall Number of Participants Analyzed 259 242 247 256
Measure Type: Number
Unit of Measure: percentage of participants
8.1 2.1 10.5 19.5
6.Secondary Outcome
Title Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment
Hide Description cEVR was defined as serum HCV RNA < LOQ after 12 weeks of treatment.
Time Frame after 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Hide Arm/Group Description:
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
ALV Placebo with PEG and RBV for 48 weeks
Overall Number of Participants Analyzed 259 242 247 256
Measure Type: Number
Unit of Measure: percentage of participants
89.6 96.3 89.1 70.3
7.Secondary Outcome
Title Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment
Hide Description eRVR was defined as achieving RVR4 and maintaining HCV RNA < LOQ until Week 12.
Time Frame from 4 to 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Hide Arm/Group Description:
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
ALV Placebo with PEG and RBV for 48 weeks
Overall Number of Participants Analyzed 259 242 247 256
Measure Type: Number
Unit of Measure: percentage of participants
60.2 71.1 56.7 28.1
8.Secondary Outcome
Title Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks
Hide Description ETR was defined as serum HCV RNA < LOQ at treatment end (completed or prematurely discontinued).
Time Frame at treatment end within 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Hide Arm/Group Description:
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
ALV Placebo with PEG and RBV for 48 weeks
Overall Number of Participants Analyzed 271 268 264 265
Measure Type: Number
Unit of Measure: percentage of participants
88.2 87.7 87.5 80.0
9.Secondary Outcome
Title Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks
Hide Description

ALT abnormalities were summarized as participants who had either:

  • ALT > 2 x upper limit of normal (ULN) during the study and > 2 x ULN at baseline
  • ALT > 3 x ULN during the study and > 2 x ULN at baseline
Time Frame within 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Set, defined as having received at least one dose of study medication, with available data
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Hide Arm/Group Description:
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
ALV Placebo with PEG and RBV for 48 weeks
Overall Number of Participants Analyzed 271 267 264 264
Measure Type: Number
Unit of Measure: percentage of participants
> 2 x ULN and > 2 x baseline 1.5 0.4 1.9 1.5
> 3 x ULN and > 2 x baseline 0.7 0.0 1.5 0.8
10.Secondary Outcome
Title Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks
Hide Description

Grading was according to the Modified Division of Microbiology & Infectious Diseases (DMID) Toxicity Tables (version 2.0).

Participants with multiple abnormalities were counted only once in the worst category.

Time Frame within 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Set with available data
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Hide Arm/Group Description:
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
ALV Placebo with PEG and RBV for 48 weeks
Overall Number of Participants Analyzed 271 267 264 264
Measure Type: Number
Unit of Measure: percentage of participants
Grade 3 1.8 3.4 0.8 1.9
Grade 4 0.0 0.4 0.0 0.0
11.Secondary Outcome
Title Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks
Hide Description Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.
Time Frame within 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Set with available data
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Hide Arm/Group Description:
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
ALV Placebo with PEG and RBV for 48 weeks
Overall Number of Participants Analyzed 270 263 264 264
Measure Type: Number
Unit of Measure: percentage of participants
Grade 3 24.4 24.7 23.1 12.9
Grade 4 4.4 8.0 7.2 2.7
12.Secondary Outcome
Title Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks
Hide Description Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.
Time Frame within 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Set with available data
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Hide Arm/Group Description:
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
ALV Placebo with PEG and RBV for 48 weeks
Overall Number of Participants Analyzed 270 265 264 264
Measure Type: Number
Unit of Measure: percentage of participants
Grade 3 6.7 21.9 12.5 1.9
Grade 4 0.0 1.1 0.0 0.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Hide Arm/Group Description Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT) Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks ALV Placebo with PEG and RBV for 48 weeks
All-Cause Mortality
Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/273 (8.79%)   28/268 (10.45%)   21/265 (7.92%)   28/265 (10.57%) 
Blood and lymphatic system disorders         
Anaemia  1  2/273 (0.73%)  1/268 (0.37%)  0/265 (0.00%)  2/265 (0.75%) 
Neutropenia  1  2/273 (0.73%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Febrile neutropenia  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Pancytopenia  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Spontaneous haematoma  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Thrombocytopenia  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Cardiac disorders         
Tachycardia  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  1/265 (0.38%) 
Atrial fibrillation  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Cardiac failure  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Hypertensive heart disease  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Ear and labyrinth disorders         
Vertigo  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  1/265 (0.38%) 
Acute vestibular syndrome  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Deafness neurosensory  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Endocrine disorders         
Thyroiditis  1  0/273 (0.00%)  0/268 (0.00%)  2/265 (0.75%)  0/265 (0.00%) 
Autoimmune thyroiditis  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Hyperthyroidism  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Eye disorders         
Dacryoadenitis acquired  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Gastrointestinal disorders         
Pancreatitis acute  1  0/273 (0.00%)  3/268 (1.12%)  1/265 (0.38%)  1/265 (0.38%) 
Vomiting  1  0/273 (0.00%)  2/268 (0.75%)  0/265 (0.00%)  2/265 (0.75%) 
Abdominal pain  1  0/273 (0.00%)  2/268 (0.75%)  0/265 (0.00%)  1/265 (0.38%) 
Nausea  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Pancreatitis  1  1/273 (0.37%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Diarrhoea  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Gastritis  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Haematemesis  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Haemorrhoidal haemorrhage  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Haemorrhoids  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Small intestinal obstruction  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Upper gastrointestinal haemorrhage  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
General disorders         
Pyrexia  1  1/273 (0.37%)  2/268 (0.75%)  0/265 (0.00%)  0/265 (0.00%) 
Drug interaction  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Fatigue  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Influenza like illness  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Lipogranuloma  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Multi-organ failure  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Non-cardiac chest pain  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Pain  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Hepatobiliary disorders         
Cholecystitis  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Cholecystitis acute  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Cholelithiasis  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Hepatosplenomegaly  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Infections and infestations         
Appendicitis  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  2/265 (0.75%) 
Bronchitis  1  1/273 (0.37%)  2/268 (0.75%)  0/265 (0.00%)  0/265 (0.00%) 
Pneumonia  1  1/273 (0.37%)  1/268 (0.37%)  1/265 (0.38%)  0/265 (0.00%) 
Urinary tract infection  1  2/273 (0.73%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Bronchopneumonia  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Cellulitis  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Cervicitis  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Enterocolitis infectious  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Gastroenteritis  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Influenza  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Lobar pneumonia  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Nasal abscess  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Pulmonary tuberculosis  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Salpingo-oophoritis  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Tooth abscess  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Injury, poisoning and procedural complications         
Lower limb fracture  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Radius fracture  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Road traffic accident  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Metabolism and nutrition disorders         
Diabetic ketoacidosis  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Hypokalaemia  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Hypomagnesaemia  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Hyponatraemia  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Type 2 diabetes mellitus  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Musculoskeletal and connective tissue disorders         
Bursitis  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Exostosis  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Cervix carcinoma  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Craniopharyngioma  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Hepatocellular carcinoma  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Leiomyosarcoma  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Meningioma  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Pancreatic neoplasm  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Pituitary tumour benign  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Prostatic adenoma  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Squamous cell carcinoma of the cervix  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Nervous system disorders         
Dizziness  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  1/265 (0.38%) 
Headache  1  0/273 (0.00%)  1/268 (0.37%)  1/265 (0.38%)  0/265 (0.00%) 
Subarachnoid haemorrhage  1  1/273 (0.37%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Syncope  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  1/265 (0.38%) 
Hemiparesis  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Intraventricular haemorrhage  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Paraesthesia  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Psychiatric disorders         
Depression  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Mania  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  1/265 (0.38%) 
Suicidal ideation  1  0/273 (0.00%)  2/268 (0.75%)  0/265 (0.00%)  0/265 (0.00%) 
Anxiety  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Major depression  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Schizophrenia, paranoid type  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Suicide attempt  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Reproductive system and breast disorders         
Bartholinitis  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Benign prostatic hyperplasia  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Dysfunctional uterine bleeding  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Ovarian disorder  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary fibrosis  1  0/273 (0.00%)  0/268 (0.00%)  2/265 (0.75%)  0/265 (0.00%) 
Acute respiratory failure  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Chronic obstructive pulmonary disease  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Dyspnoea  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Epistaxis  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Tonsillar hypertrophy  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Skin and subcutaneous tissue disorders         
Eczema  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Urticaria  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Vascular disorders         
Hypertensive crisis  1  0/273 (0.00%)  3/268 (1.12%)  0/265 (0.00%)  0/265 (0.00%) 
Hypertension  1  0/273 (0.00%)  1/268 (0.37%)  1/265 (0.38%)  0/265 (0.00%) 
Aortic dissection  1  0/273 (0.00%)  0/268 (0.00%)  0/265 (0.00%)  1/265 (0.38%) 
Deep vein thrombosis  1  0/273 (0.00%)  1/268 (0.37%)  0/265 (0.00%)  0/265 (0.00%) 
Hypotension  1  1/273 (0.37%)  0/268 (0.00%)  0/265 (0.00%)  0/265 (0.00%) 
Vasculitis  1  0/273 (0.00%)  0/268 (0.00%)  1/265 (0.38%)  0/265 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   256/273 (93.77%)   261/268 (97.39%)   250/265 (94.34%)   242/265 (91.32%) 
Blood and lymphatic system disorders         
Anaemia  1  113/273 (41.39%)  124/268 (46.27%)  91/265 (34.34%)  88/265 (33.21%) 
Leukopenia  1  48/273 (17.58%)  27/268 (10.07%)  48/265 (18.11%)  27/265 (10.19%) 
Lymphopenia  1  15/273 (5.49%)  7/268 (2.61%)  16/265 (6.04%)  8/265 (3.02%) 
Neutropenia  1  86/273 (31.50%)  80/268 (29.85%)  86/265 (32.45%)  67/265 (25.28%) 
Thrombocytopenia  1  47/273 (17.22%)  73/268 (27.24%)  49/265 (18.49%)  16/265 (6.04%) 
Endocrine disorders         
Hypothyroidism  1  17/273 (6.23%)  22/268 (8.21%)  23/265 (8.68%)  12/265 (4.53%) 
Eye disorders         
Ocular icterus  1  11/273 (4.03%)  14/268 (5.22%)  5/265 (1.89%)  4/265 (1.51%) 
Gastrointestinal disorders         
Abdominal pain upper  1  18/273 (6.59%)  24/268 (8.96%)  22/265 (8.30%)  15/265 (5.66%) 
Constipation  1  12/273 (4.40%)  17/268 (6.34%)  7/265 (2.64%)  12/265 (4.53%) 
Diarrhoea  1  30/273 (10.99%)  27/268 (10.07%)  38/265 (14.34%)  37/265 (13.96%) 
Dyspepsia  1  23/273 (8.42%)  17/268 (6.34%)  32/265 (12.08%)  18/265 (6.79%) 
Gastrooesophageal reflux disease  1  11/273 (4.03%)  9/268 (3.36%)  7/265 (2.64%)  15/265 (5.66%) 
Nausea  1  66/273 (24.18%)  67/268 (25.00%)  62/265 (23.40%)  45/265 (16.98%) 
Vomiting  1  26/273 (9.52%)  39/268 (14.55%)  29/265 (10.94%)  19/265 (7.17%) 
General disorders         
Asthenia  1  43/273 (15.75%)  46/268 (17.16%)  46/265 (17.36%)  48/265 (18.11%) 
Chills  1  23/273 (8.42%)  30/268 (11.19%)  33/265 (12.45%)  21/265 (7.92%) 
Fatigue  1  84/273 (30.77%)  99/268 (36.94%)  87/265 (32.83%)  86/265 (32.45%) 
Influenza like illness  1  56/273 (20.51%)  52/268 (19.40%)  38/265 (14.34%)  40/265 (15.09%) 
Injection site erythema  1  14/273 (5.13%)  10/268 (3.73%)  17/265 (6.42%)  8/265 (3.02%) 
Irritability  1  19/273 (6.96%)  16/268 (5.97%)  21/265 (7.92%)  22/265 (8.30%) 
Pyrexia  1  78/273 (28.57%)  93/268 (34.70%)  82/265 (30.94%)  74/265 (27.92%) 
Hepatobiliary disorders         
Hyperbilirubinaemia  1  32/273 (11.72%)  61/268 (22.76%)  25/265 (9.43%)  2/265 (0.75%) 
Jaundice  1  7/273 (2.56%)  20/268 (7.46%)  3/265 (1.13%)  1/265 (0.38%) 
Infections and infestations         
Nasopharyngitis  1  9/273 (3.30%)  9/268 (3.36%)  17/265 (6.42%)  12/265 (4.53%) 
Upper respiratory tract infection  1  16/273 (5.86%)  5/268 (1.87%)  16/265 (6.04%)  13/265 (4.91%) 
Urinary tract infection  1  11/273 (4.03%)  14/268 (5.22%)  11/265 (4.15%)  8/265 (3.02%) 
Investigations         
Weight decreased  1  24/273 (8.79%)  28/268 (10.45%)  26/265 (9.81%)  18/265 (6.79%) 
Metabolism and nutrition disorders         
Decreased appetite  1  61/273 (22.34%)  59/268 (22.01%)  58/265 (21.89%)  42/265 (15.85%) 
Hypertriglyceridaemia  1  11/273 (4.03%)  23/268 (8.58%)  22/265 (8.30%)  14/265 (5.28%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  38/273 (13.92%)  35/268 (13.06%)  39/265 (14.72%)  29/265 (10.94%) 
Back pain  1  18/273 (6.59%)  14/268 (5.22%)  15/265 (5.66%)  20/265 (7.55%) 
Muscle spasms  1  8/273 (2.93%)  17/268 (6.34%)  7/265 (2.64%)  10/265 (3.77%) 
Myalgia  1  59/273 (21.61%)  53/268 (19.78%)  56/265 (21.13%)  52/265 (19.62%) 
Nervous system disorders         
Dizziness  1  33/273 (12.09%)  34/268 (12.69%)  25/265 (9.43%)  30/265 (11.32%) 
Dysgeusia  1  14/273 (5.13%)  22/268 (8.21%)  13/265 (4.91%)  11/265 (4.15%) 
Headache  1  91/273 (33.33%)  94/268 (35.07%)  94/265 (35.47%)  80/265 (30.19%) 
Psychiatric disorders         
Anxiety  1  17/273 (6.23%)  20/268 (7.46%)  25/265 (9.43%)  29/265 (10.94%) 
Depression  1  20/273 (7.33%)  29/268 (10.82%)  28/265 (10.57%)  23/265 (8.68%) 
Insomnia  1  49/273 (17.95%)  61/268 (22.76%)  50/265 (18.87%)  60/265 (22.64%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  47/273 (17.22%)  54/268 (20.15%)  59/265 (22.26%)  53/265 (20.00%) 
Dyspnoea  1  37/273 (13.55%)  26/268 (9.70%)  23/265 (8.68%)  26/265 (9.81%) 
Epistaxis  1  12/273 (4.40%)  25/268 (9.33%)  15/265 (5.66%)  10/265 (3.77%) 
Oropharyngeal pain  1  15/273 (5.49%)  13/268 (4.85%)  19/265 (7.17%)  11/265 (4.15%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  60/273 (21.98%)  45/268 (16.79%)  57/265 (21.51%)  47/265 (17.74%) 
Dry skin  1  21/273 (7.69%)  23/268 (8.58%)  31/265 (11.70%)  22/265 (8.30%) 
Pruritus  1  58/273 (21.25%)  55/268 (20.52%)  49/265 (18.49%)  54/265 (20.38%) 
Rash  1  46/273 (16.85%)  40/268 (14.93%)  45/265 (16.98%)  45/265 (16.98%) 
Vascular disorders         
Hypertension  1  31/273 (11.36%)  50/268 (18.66%)  34/265 (12.83%)  7/265 (2.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
In April 2012, ALV and placebo were discontinued in all participants. Participants remained on PEG and RBV treatment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Vice President Clinical Research & Development
Organization: Debiopharm International S.A.
Phone: 4121 321 01 11
Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT01318694     History of Changes
Other Study ID Numbers: CDEB025A2301
2010-022867-37 ( EudraCT Number )
First Submitted: March 17, 2011
First Posted: March 18, 2011
Results First Submitted: August 5, 2016
Results First Posted: September 30, 2016
Last Update Posted: September 30, 2016