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

• Sponsor: Debiopharm International SA (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01500772
• Collaborator: (none)
• Enrollment: 6
• Locations: 60
• Arm: 1
• Duration (Months): 2
• Patients Per Site: 0.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease inhibitor (PI).

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: Alisporivir; Drug: Peginterferon alfa-2a; Drug: Ribavirin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Single-arm Trial Evaluating the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-IFNα2a/RBV) in Protease Inhibitor Treatment Failure Patients With Chronic Hepatitis C Genotype 1
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alisporivir ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks	Drug: Alisporivir; ALV 200 mg soft gel capsules administered orally; Other Names: DEB025 ; Drug: Peginterferon alfa-2a; PEG 180 μg administered via subcutaneous (s.c.) injection once weekly; Other Names: Pegasys® ; Drug: Ribavirin; RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose; Other Names: Copegus® RBV

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12) [12 weeks posttreatment]

   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.

Secondary Outcome Measures

1. Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24) [24 weeks posttreatment]

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

2. Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD) [12 weeks posttreatment]

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

3. Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events [48 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

1. Patients with chronic HCV genotype 1 infection with previous PI treatment failure

2. Three months minimum time from the last dose of previous PI treatment to the first dose of study medication

Exclusion criteria:

1. Use of other investigational drugs at the time of enrollment

2. History of hypersensitivity to PEG or RBV

3. Any null non-responders to prior PEG/RBV treatment

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Phoenix	Arizona	United States	85054
2	Novartis Investigative Site	Bakersfield	California	United States	93301
3	Novartis Investigative Site	Los Angeles	California	United States	90033
4	Novartis Investigative Site	Palo Alto	California	United States	95128
5	Novartis Investigative Site	Sacramento	California	United States	95817
6	Novartis Investigative Site	San Diego	California	United States	92114
7	Novartis Investigative Site	San Diego	California	United States	92128
8	Novartis Investigative Site	Ventura	California	United States	93003
9	Novartis Investigational site	Bradenton	Florida	United States	34209
10	Novartis Investigative Site	Bradenton	Florida	United States	34209
11	Novartis Investigative Site	Miami	Florida	United States	33136
12	Novartis Investigative Site	Wellington	Florida	United States	33414
13	Novartis Investigative Site	Chicago	Illinois	United States	60611
14	Novartis Investigative Site	Baltimore	Maryland	United States	21229
15	Novartis Investigative Site	Brockton	Massachusetts	United States	02302
16	Novartis Investigative Site	Minneapolis	Minnesota	United States	55404
17	Novartis Investigative Site	St. Louis	Missouri	United States	63110
18	Novartis Investigative Site	New York	New York	United States	10021
19	Novartis Investigative Site	New York	New York	United States	10029
20	Novartis Investigative Site	New York	New York	United States	10032
21	Novartis Investigative Site	Cincinnati	Ohio	United States	45267
22	Novartis Investigative Site	Providence	Rhode Island	United States	02905
23	Novartis Investigative Site	Arlington	Texas	United States	76012
24	Novartis Investigative Site	Dallas	Texas	United States	75246
25	Novartis Investigative Site	Alexandria	Virginia	United States	22306
26	Novartis Investigative Site	Newport News	Virginia	United States	23602
27	Novartis Investigative Site	Vancouver	British Columbia	Canada	V5Z 1J4
28	Novartis Investigative Site	Vancouver	British Columbia	Canada	v6z 2k5
29	Novartis Investigative Site	Clichy		France	92110
30	Novartis Investigative Site	Creteil		France	94000
31	Novartis Investigative Site	Paris		France	75006
32	Novartis Investigational Site	Berlin		Germany	10969
33	Novartis Investigative Site	Berlin		Germany	10969
34	Novartis Investigative Site	Berlin		Germany	13353
35	Novartis Investigative Site	Duesseldorf		Germany	40225
36	Novartis Investigative Site	Düsseldorf		Germany	40237
37	Novartis Investigative Site	Frankfurt		Germany	60590
38	Novartis Investigative Site	Freiburg		Germany	79106
39	Novartis Investigational Site	Frieburg		Germany	79106
40	Novartis Investigative Site	Hamburg		Germany	20099
41	Novartis Investigative Site	Hannover		Germany	30625
42	Novartis Investigative Site	Heidelberg		Germany	69120
43	Novartis Investigative Site	Kiel		Germany	24146
44	Novartis Investigational Site	Koln		Germany	50924
45	Novartis Investigative Site	Köln		Germany	50924
46	Novartis Investigational Site	Mainz		Germany	55131
47	Novartis Investigative Site	Mainz		Germany	55131
48	Novartis Investigative Site	Firenze	FI	Italy	50134
49	Novartis Investigative Site	Milano	MI	Italy	20122
50	Novartis Investigative Site	Modena	MO	Italy	41124
51	Novartis Investigative Site	Palermo	PA	Italy	90127
52	Novartis Investigative Site	Padova	PD	Italy	35128
53	Novartis Investigative Site	Roma	RM	Italy	00161
54	Novartis Investigative Site	Torino	TO	Italy	10126
55	Novartis Investigative Site	Bologna		Italy	40138
56	Novartis Investigative Site	San Juan		Puerto Rico	00909
57	Novartis Investigative Site	Majadanonda	Madrid	Spain	28222
58	Novartis Investigative Site	Barcelona		Spain	08035
59	Novartis Investigative Site	London		United Kingdom	NW3 3QG
60	Novartis Investigative Site	London		United Kingdom	SE5 9RS

Sponsors and Collaborators

• Debiopharm International SA

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Debiopharm International SA
• ClinicalTrials.gov Identifier: NCT01500772
• Other Study ID Numbers: CDEB025A2306; 2011-004653-31
• First Posted: Dec 28, 2011
• Last Update Posted: Aug 1, 2016
• Last Verified: Jun 1, 2016

• Keywords provided by Debiopharm International SA: Hepatitis C; PI treatment failure
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Ribavirin; Peginterferon alfa-2a

Study Results

Participant Flow

Arm/Group Title	Alisporivir
Arm/Group Description	Alisporivir (ALV) 400 mg twice daily (BID), with peginterferon alfa-2a (PEG) and ribavirin (RBV) for 48 weeks.
Period Title: Overall Study
STARTED	6
COMPLETED	0
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Alisporivir
Arm/Group Description	ALV 400 mg BID with PEG and RBV for 48 weeks.
Overall Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	3 50%
Male	3 50%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)
Description	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.
Time Frame	12 weeks posttreatment

Outcome Measure Data

Analysis Population Description

The study was terminated before the outcome measure time point.

Arm/Group Title	Alisporivir
Arm/Group Description	ALV 400 mg BID with PEG and RBV for 48 weeks.
Measure Participants	0

2. Secondary Outcome

Title	Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)
Description	SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.
Time Frame	24 weeks posttreatment

Outcome Measure Data

Analysis Population Description

The study was terminated before the outcome measure time point.

Arm/Group Title	Alisporivir
Arm/Group Description	ALV 400 mg BID with PEG and RBV for 48 weeks.
Measure Participants	0

3. Secondary Outcome

Title	Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD)
Description	Level of detection (LOD) was defined as 10 IU/mL
Time Frame	12 weeks posttreatment

Outcome Measure Data

Analysis Population Description

The study was terminated before the outcome measure time point.

Arm/Group Title	Alisporivir
Arm/Group Description	ALV 400 mg BID with PEG and RBV for 48 weeks.
Measure Participants	0

4. Secondary Outcome

Title	Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description

The study was terminated before the outcome measure time point.

Arm/Group Title	Alisporivir
Arm/Group Description	ALV 400 mg BID with PEG and RBV for 48 weeks.
Measure Participants	0

Adverse Events

Time Frame	Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
Arm/Group Title	Alisporivir
Arm/Group Description	ALV 400 mg BID with PEG and RBV for 48 weeks.
All Cause Mortality
	Alisporivir
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Alisporivir
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	Alisporivir
	Affected / at Risk (%)	# Events
Total	5/6 (83.3%)
Blood and lymphatic system disorders
Thrombocytopenia	2/6 (33.3%)
Neutropenia	1/6 (16.7%)
Gastrointestinal disorders
Nausea	2/6 (33.3%)
General disorders
Pyrexia	3/6 (50%)
Fatigue	1/6 (16.7%)
Chills	1/6 (16.7%)
Asthenia	1/6 (16.7%)
Infections and infestations
Nasopharyngitis	1/6 (16.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/6 (16.7%)
Bone Pain	1/6 (16.7%)
Myalgia	1/6 (16.7%)
Nervous system disorders
Headache	4/6 (66.7%)
Psychiatric disorders
Sleep Disorder	1/6 (16.7%)
Skin and subcutaneous tissue disorders
Hyperhidrosis	1/6 (16.7%)
Dry Skin	1/6 (16.7%)
Rash Pruritic	2/6 (33.3%)
Skin Fissures	1/6 (16.7%)
Seborrhoeic Dermatitis	1/6 (16.7%)
Vascular disorders
Hypertension	1/6 (16.7%)

Limitations/Caveats

Due to early termination of the study, none of the planned outcome measures could be evaluated.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.