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Trial record 67 of 295 for:    IFNA2 AND PEG-interferon alfa-2b

A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3 (ACTIVATE)

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ClinicalTrials.gov Identifier: NCT01364090
Recruitment Status : Completed
First Posted : June 2, 2011
Results First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kirby Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: Pegylated interferon alfa 2b
Drug: Ribavirin
Enrollment 93
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Treatment Duration (24 Weeks) Shortened Treatment Duration (12 Weeks) Discontinued Prior to RVR
Hide Arm/Group Description

Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).

Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.

Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.

Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).

Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.

Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.

Participants who discontinued therapy prior to RVR assessment at week 4 and were therefore not placed in either study arms.
Period Title: Overall Study
Started [1] 26 61 6
Completed 12 58 0
Not Completed 14 3 6
[1]
Six participants discontinued treatment prior to RVR at week 4 and were not placed in an arm.
Arm/Group Title Standard Treatment Duration (24 Weeks) Shortened Treatment Duration (12 Weeks) Discontinued Prior to RVR Total
Hide Arm/Group Description

Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).

Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.

Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.

Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).

Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.

Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.

Participants who discontinued therapy prior to RVR assessment at week 4 and were therefore not placed in either study arms. Total of all reporting groups
Overall Number of Baseline Participants 26 61 6 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 26 participants 61 participants 6 participants 93 participants
40
(35 to 48)
41
(34 to 49)
50
(41 to 56)
41
(35 to 49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 61 participants 6 participants 93 participants
Female
3
  11.5%
12
  19.7%
1
  16.7%
16
  17.2%
Male
23
  88.5%
49
  80.3%
5
  83.3%
77
  82.8%
1.Primary Outcome
Title Treatment Efficacy
Hide Description The primary outcome measure is the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable (<15 IU/ml detected and <15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Treatment Duration (24 Weeks) Shortened Treatment Duration (12 Weeks) Discontinued Prior to RVR
Hide Arm/Group Description:

Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).

Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.

Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.

Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).

Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.

Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.

Participants who discontinued therapy prior to RVR assessment at week 4 and were therefore not placed in either study arms.
Overall Number of Participants Analyzed 26 61 6
Measure Type: Number
Unit of Measure: participants
10 51 0
2.Secondary Outcome
Title Safety and Tolerability
Hide Description Evaluate the safety and tolerability of directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.
Time Frame 48 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Treatment Adherence
Hide Description Evaluate the adherence (>80 of PEG-IFN, >80% of RBV, >80% of time) to directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.
Time Frame 48 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Treatment Response (ETR & SVR24)
Hide Description Evaluate the percentage with undetectable HCV RNA at end of treatment (ETR) and 24 weeks post end of treatment (SVR24) in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non quantifiable HCV RNA or undetectable HCV RNA at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy.
Time Frame 48 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Behavioral and Quality of Life
Hide Description Evaluate changes in illicit drug use, opiate substitution therapy, depression, suicidal ideations and health-related quality of life in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy.
Time Frame 48 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Treatment Duration (24 Weeks) Shortened Treatment Duration (12 Weeks) Discontinued Prior to RVR
Hide Arm/Group Description

Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).

Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.

Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.

Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).

Pegylated interferon alfa 2b: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.

Ribavirin: Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.

Participants who discontinued therapy prior to RVR assessment at week 4 and were therefore not placed in either study arms.
All-Cause Mortality
Standard Treatment Duration (24 Weeks) Shortened Treatment Duration (12 Weeks) Discontinued Prior to RVR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Treatment Duration (24 Weeks) Shortened Treatment Duration (12 Weeks) Discontinued Prior to RVR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/26 (15.38%)   6/61 (9.84%)   1/6 (16.67%) 
Cardiac disorders       
Cardiac disorders  0/26 (0.00%)  1/61 (1.64%)  0/6 (0.00%) 
General disorders       
Gastrointestinal disorders  0/26 (0.00%)  1/61 (1.64%)  0/6 (0.00%) 
General disorders and administration site conditions  0/26 (0.00%)  1/61 (1.64%)  0/6 (0.00%) 
Infections and infestations       
Infections and infestations  2/26 (7.69%)  1/61 (1.64%)  0/6 (0.00%) 
Injury, poisoning and procedural complications       
Injury, poisoning and procedural complications  2/26 (7.69%)  2/61 (3.28%)  1/6 (16.67%) 
Nervous system disorders       
Nervous system disorders  0/26 (0.00%)  1/61 (1.64%)  0/6 (0.00%) 
Psychiatric disorders       
Psychiatric disorders  1/26 (3.85%)  1/61 (1.64%)  0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Treatment Duration (24 Weeks) Shortened Treatment Duration (12 Weeks) Discontinued Prior to RVR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   26/26 (100.00%)   60/61 (98.36%)   5/6 (83.33%) 
Blood and lymphatic system disorders       
Blood and lymphatic system disorders  7/26 (26.92%)  13/61 (21.31%)  0/6 (0.00%) 
Cardiac disorders       
Cardiac disorders  0/26 (0.00%)  4/61 (6.56%)  0/6 (0.00%) 
Ear and labyrinth disorders       
Ear and labyrinth disorders  3/26 (11.54%)  0/61 (0.00%)  0/6 (0.00%) 
Eye disorders       
Eye disorders  3/26 (11.54%)  11/61 (18.03%)  0/6 (0.00%) 
Gastrointestinal disorders       
Gastrointestinal disorders  14/26 (53.85%)  43/61 (70.49%)  3/6 (50.00%) 
General disorders       
General disorders and administration site conditions  23/26 (88.46%)  55/61 (90.16%)  4/6 (66.67%) 
Infections and infestations       
Infections and infestations  10/26 (38.46%)  13/61 (21.31%)  0/6 (0.00%) 
Injury, poisoning and procedural complications       
Injury, poisoning and procedural complications  7/26 (26.92%)  13/61 (21.31%)  1/6 (16.67%) 
Investigations       
Investigations  4/26 (15.38%)  7/61 (11.48%)  0/6 (0.00%) 
Metabolism and nutrition disorders       
Metabolism and nutrition disorders  7/26 (26.92%)  19/61 (31.15%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal and connective tissue disorders  11/26 (42.31%)  26/61 (42.62%)  1/6 (16.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps)  1/26 (3.85%)  0/61 (0.00%)  0/6 (0.00%) 
Nervous system disorders       
Nervous system disorders  19/26 (73.08%)  35/61 (57.38%)  0/6 (0.00%) 
Psychiatric disorders       
Psychiatric disorders  15/26 (57.69%)  37/61 (60.66%)  1/6 (16.67%) 
Renal and urinary disorders       
Renal and urinary disorders  1/26 (3.85%)  1/61 (1.64%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory, thoracic and mediastinal disorders  9/26 (34.62%)  15/61 (24.59%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders       
Skin and subcutaneous tissue disorders  14/26 (53.85%)  30/61 (49.18%)  0/6 (0.00%) 
Surgical and medical procedures       
Surgical and medical procedures  0/26 (0.00%)  1/61 (1.64%)  0/6 (0.00%) 
Vascular disorders       
Vascular disorders  2/26 (7.69%)  4/61 (6.56%)  0/6 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jason Grebely
Organization: Viral Hepatits Clinical Research Program - The Kirby Institute - UNSW Sydney
Phone: +61 2938 50957
EMail: Jgrebely@kirby.unsw.edu.au
Layout table for additonal information
Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT01364090     History of Changes
Other Study ID Numbers: VHCRP1007
First Submitted: May 31, 2011
First Posted: June 2, 2011
Results First Submitted: May 24, 2017
Results First Posted: October 18, 2017
Last Update Posted: October 18, 2017