Trial Outcomes & Findings for Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C (NCT NCT01500772)

NCT ID: NCT01500772

Last Updated: 2016-08-01

Results Overview

SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 6 participants
• Primary outcome timeframe: 12 weeks posttreatment
• Results posted on: 2016-08-01

Participant Flow

Participant milestones

Measure	Alisporivir Alisporivir (ALV) 400 mg twice daily (BID), with peginterferon alfa-2a (PEG) and ribavirin (RBV) for 48 weeks.
Overall Study STARTED	6
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C

Baseline characteristics by cohort

Measure	Alisporivir n=6 Participants ALV 400 mg BID with PEG and RBV for 48 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks posttreatment

Population: The study was terminated before the outcome measure time point.

SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks posttreatment

Population: The study was terminated before the outcome measure time point.

SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks posttreatment

Population: The study was terminated before the outcome measure time point.

Level of detection (LOD) was defined as 10 IU/mL

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks

Population: The study was terminated before the outcome measure time point.

Outcome measures

Outcome data not reported

Adverse Events

Alisporivir

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Alisporivir n=6 participants at risk ALV 400 mg BID with PEG and RBV for 48 weeks.
Infections and infestations Nasopharyngitis	16.7% 1/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
General disorders Pyrexia	50.0% 3/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
Nervous system disorders Headache	66.7% 4/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
Blood and lymphatic system disorders Thrombocytopenia	33.3% 2/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
Blood and lymphatic system disorders Neutropenia	16.7% 1/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
General disorders Fatigue	16.7% 1/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
Gastrointestinal disorders Nausea	33.3% 2/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
Skin and subcutaneous tissue disorders Hyperhidrosis	16.7% 1/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
Vascular disorders Hypertension	16.7% 1/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
Skin and subcutaneous tissue disorders Dry Skin	16.7% 1/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
Skin and subcutaneous tissue disorders Rash Pruritic	33.3% 2/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
General disorders Chills	16.7% 1/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
Skin and subcutaneous tissue disorders Skin Fissures	16.7% 1/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
Skin and subcutaneous tissue disorders Seborrhoeic Dermatitis	16.7% 1/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
Musculoskeletal and connective tissue disorders Bone Pain	16.7% 1/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
Psychiatric disorders Sleep Disorder	16.7% 1/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
General disorders Asthenia	16.7% 1/6 • Baseline to end of treatment (maximum exposure: 25 days) plus 30 days

Additional Information

Vice President, Clinical Research and Development

Debiopharm International S.A.

Phone: 4121 321 01 11

Email: info-international@debiopharm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER