Trial Outcomes & Findings for Long Term Follow-up Study to Assess Durability of Sustained Virologic Response in Alisporivir-treated Hepatitis C Patients (NCT NCT02753699)

NCT ID: NCT02753699

Last Updated: 2016-08-26

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

723 participants

Primary outcome timeframe

up to 120 Weeks

Results posted on

2016-08-26

Participant Flow

The study was conducted in 127 centers across 22 countries globally.

Participants transferring from Study 2211 were allocated to the "From Study 2211 group". These were evaluated as INF-free and Overall subgroups for efficacy analyses.

Participant milestones

Participant milestones
Measure	From Study 2210 All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.	From Study 2301 All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.	From Study 2211 All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
Overall Study STARTED	164	397	162
Overall Study COMPLETED	150	354	139
Overall Study NOT COMPLETED	14	43	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long Term Follow-up Study to Assess Durability of Sustained Virologic Response in Alisporivir-treated Hepatitis C Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	From Study 2210 n=164 Participants All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.	From Study 2301 n=397 Participants All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.	From Study 2211 n=162 Participants All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.	Total n=723 Participants Total of all reporting groups
Age, Continuous	52.5 years STANDARD_DEVIATION 9.89 • n=5 Participants	46.4 years STANDARD_DEVIATION 11.70 • n=7 Participants	43.7 years STANDARD_DEVIATION 10.89 • n=5 Participants	47.2 years STANDARD_DEVIATION 11.53 • n=4 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	182 Participants n=7 Participants	61 Participants n=5 Participants	301 Participants n=4 Participants
Sex: Female, Male Male	106 Participants n=5 Participants	215 Participants n=7 Participants	101 Participants n=5 Participants	422 Participants n=4 Participants

PRIMARY outcome

Timeframe: up to 120 Weeks

Population: Full analysis set (FAS), defined as all participants who enrolled into this study and had at least one HCV RNA assessment, unless excluded due to protocol deviations.

Outcome measures

Outcome measures
Measure	From Study 2210 n=161 Participants All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.	From Study 2301 n=383 Participants All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.	From Study 2211 IFN-free n=53 Participants Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.	From Study 2211 Overall n=160 Participants All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 Week 1 (n=152,371,53,152)	96.7 percentage of participants	99.5 percentage of participants	100.0 percentage of participants	100.0 percentage of participants
Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 Week 96 (n=7,0,36,90)	100.0 percentage of participants	0.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants
Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 Week 120 (n=0,0,1,3)	0.0 percentage of participants	0.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants
Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 Week 24 (n=148,346,49,148)	100.0 percentage of participants	100.0 percentage of participants	98.0 percentage of participants	99.3 percentage of participants
Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 Week 48 (n=146,337,46,140)	100.0 percentage of participants	99.7 percentage of participants	100.0 percentage of participants	100.0 percentage of participants
Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 Overall (n=161,383,53,160)	96.9 percentage of participants	99.2 percentage of participants	98.1 percentage of participants	99.4 percentage of participants

SECONDARY outcome

Timeframe: at Week 48

Population: Full analysis set. In the categories, n is the number of subjects in FAS in the appropriate study group with normal ALT at visit; for Overall - at all available visits.

Note that the 24-week period between end of feeder study (SVR24) and first visit in this follow-up study is not counted in the 48 weeks, so this timepoint corresponds to 96 weeks (=24+24+48) after the last dose of alisporivir.

Outcome measures

Outcome measures
Measure	From Study 2210 n=161 Participants All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.	From Study 2301 n=383 Participants All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.	From Study 2211 IFN-free n=53 Participants Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.	From Study 2211 Overall n=160 Participants All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. Week 96 (n=7,0,36,92)	85.7 percentage of participants	0.0 percentage of participants	94.4 percentage of participants	93.5 percentage of participants
Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. Overall (n=161,383,52,159)	78.9 percentage of participants	88.5 percentage of participants	78.8 percentage of participants	83.6 percentage of participants
Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. Week 1 (n=161,383,50,156)	88.8 percentage of participants	94.0 percentage of participants	96.0 percentage of participants	95.5 percentage of participants
Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. Week 24 (n=150,360,50,151)	84.0 percentage of participants	93.9 percentage of participants	82.0 percentage of participants	89.4 percentage of participants
Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. Week 48 (n=152,355,47,141)	88.2 percentage of participants	91.5 percentage of participants	87.2 percentage of participants	91.5 percentage of participants
Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. Week 120 (n=0,0,1,3)	0.0 percentage of participants	0.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants

Adverse Events

From Study 2210

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

From Study 2301

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

From Study 2211 IFN-free

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

From Study 2211 Overall

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Vice President Clinical Research & Development

Debiopharm International, S.A.

Phone: 4121 321 01 11

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	From Study 2210 n=164 participants at risk All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.	From Study 2301 n=397 participants at risk All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.	From Study 2211 IFN-free n=54 participants at risk Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.	From Study 2211 Overall n=162 participants at risk All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
Blood and lymphatic system disorders Hypochromic anaemia	0.61% 1/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Cardiac disorders Myocardial infarction	0.61% 1/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.61% 1/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Hepatobiliary disorders Cholelithiasis	0.00% 0/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.25% 1/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Infections and infestations Herpes simplex meningitis	0.00% 0/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.25% 1/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Infections and infestations Meningitis viral	0.00% 0/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.25% 1/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Infections and infestations Osteomyelitis acute	0.00% 0/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.25% 1/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Infections and infestations Otitis media chronic	0.00% 0/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.25% 1/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Infections and infestations Pneumococcal sepsis	0.61% 1/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.25% 1/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.00% 0/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.25% 1/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Injury, poisoning and procedural complications Concussion	0.00% 0/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.62% 1/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Injury, poisoning and procedural complications Contusion	0.00% 0/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.62% 1/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Injury, poisoning and procedural complications Fibula fracture	0.61% 1/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Musculoskeletal and connective tissue disorders Collagen disorder	0.61% 1/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.25% 1/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.61% 1/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.00% 0/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.62% 1/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.00% 0/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.25% 1/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.25% 1/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.61% 1/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Psychiatric disorders Alcohol abuse	0.00% 0/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.25% 1/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.
Psychiatric disorders Suicidal ideation	0.00% 0/164 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.00% 0/397 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	1.9% 1/54 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.	0.62% 1/162 • Up to 48 weeks Non-serious adverse events did not reach the 5% reporting threshold.