Trial Outcomes & Findings for Viral Kinetics in HCV Clearance in Subjects With Hemophilia (NCT NCT01704521)
NCT ID: NCT01704521
Last Updated: 2015-04-06
Results Overview
Viral kinetic assessment using SVR 12 to either "lead-in" 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
5 participants
Primary outcome timeframe
Post-treatment at week 12
Results posted on
2015-04-06
Participant Flow
January 2013 through April 2014 at Digestive Diseases Research / University of Cincinnati
Participant milestones
| Measure |
Lead-In
Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
|
No Lead-in
No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Viral Kinetics in HCV Clearance in Subjects With Hemophilia
Baseline characteristics by cohort
| Measure |
Lead-In
n=3 Participants
Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin.
|
No Lead-in
n=2 Participants
No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
37 years
n=7 Participants
|
47 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-treatment at week 12Population: See baseline characteristics
Viral kinetic assessment using SVR 12 to either "lead-in" 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment.
Outcome measures
| Measure |
Lead-In
n=3 Participants
Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
|
No Lead-in
n=2 Participants
No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration PegInterferon + Ribavirin
|
|---|---|---|
|
Number of Participants With Sustained Virological Response at Week 12 (SVR12)
|
2 participants
|
2 participants
|
Adverse Events
Lead-In
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
No Lead-in
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lead-In
n=3 participants at risk
Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
|
No Lead-in
n=2 participants at risk
No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin
|
|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
33.3%
1/3 • Number of events 1 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
0.00%
0/2 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
Other adverse events
| Measure |
Lead-In
n=3 participants at risk
Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
|
No Lead-in
n=2 participants at risk
No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin
|
|---|---|---|
|
General disorders
General disorders
|
100.0%
3/3 • Number of events 3 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
100.0%
2/2 • Number of events 2 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
100.0%
3/3 • Number of events 3 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
50.0%
1/2 • Number of events 1 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
|
Skin and subcutaneous tissue disorders
Skin and sucutaneous-tissue disorders
|
100.0%
3/3 • Number of events 3 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
50.0%
1/2 • Number of events 1 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
|
Psychiatric disorders
Psychiatric disorders
|
100.0%
3/3 • Number of events 3 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
50.0%
1/2 • Number of events 1 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
66.7%
2/3 • Number of events 2 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
50.0%
1/2 • Number of events 1 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
|
Cardiac disorders
Cardiovascular disorders
|
33.3%
1/3 • Number of events 1 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
0.00%
0/2 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
|
Musculoskeletal and connective tissue disorders
Musculoskelatal disorders
|
33.3%
1/3 • Number of events 1 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
100.0%
2/2 • Number of events 2 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders
|
33.3%
1/3 • Number of events 1 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
50.0%
1/2 • Number of events 1 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
|
Renal and urinary disorders
Genitourinary disorders
|
0.00%
0/3 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
50.0%
1/2 • Number of events 1 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
|
Infections and infestations
Infections and infestations
|
66.7%
2/3 • Number of events 2 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
0.00%
0/2 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
|
Nervous system disorders
Nervous system disorders
|
33.3%
1/3 • Number of events 1 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
50.0%
1/2 • Number of events 1 • Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place