Trial Outcomes & Findings for Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C (NCT NCT01821625)
NCT ID: NCT01821625
Last Updated: 2019-11-13
Results Overview
The length of therapy will depend on several factors: 1. Study patient's liver disease status. 2. Study patient's antiviral response. 3. Study patient's tolerance to treatment. One patient completed therapy and experienced a sustained viral response. A minimum full course of treatment will be 30 weeks, with a maximum of 56 weeks of treatment.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
7 participants
Primary outcome timeframe
Up to 56 weeks
Results posted on
2019-11-13
Participant Flow
Participant milestones
| Measure |
Thrombocytopenic (Low Platelet) Patients
All study patients will undergo intervention in this study.
The intervention will be a lead-in with eltrombopag and antiviral triple therapy (interferon, ribavirin and boceprevir).
Eltrombopag: Study patients will be provided eltrombopag to raise platelet levels before anti-hepatitis C drugs are initiated, and will continue eltrombopag throughout the study.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Thrombocytopenic (Low Platelet) Patients
All study patients will undergo intervention in this study.
The intervention will be a lead-in with eltrombopag and antiviral triple therapy (interferon, ribavirin and boceprevir).
Eltrombopag: Study patients will be provided eltrombopag to raise platelet levels before anti-hepatitis C drugs are initiated, and will continue eltrombopag throughout the study.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Medical contraindication
|
1
|
Baseline Characteristics
Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C
Baseline characteristics by cohort
| Measure |
Thrombocytopenic (Low Platelet) Patients
n=7 Participants
All study patients will undergo intervention in this study.
The intervention will be a lead-in with eltrombopag and antiviral triple therapy (interferon, ribavirin and boceprevir).
Eltrombopag: Study patients will be provided eltrombopag to raise platelet levels before anti-hepatitis C drugs are initiated, and will continue eltrombopag throughout the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 56 weeksThe length of therapy will depend on several factors: 1. Study patient's liver disease status. 2. Study patient's antiviral response. 3. Study patient's tolerance to treatment. One patient completed therapy and experienced a sustained viral response. A minimum full course of treatment will be 30 weeks, with a maximum of 56 weeks of treatment.
Outcome measures
| Measure |
Thrombocytopenic (Low Platelet) Patients
n=7 Participants
All study patients will undergo intervention in this study.
The intervention will be a lead-in with eltrombopag and antiviral triple therapy (interferon, ribavirin and boceprevir).
Eltrombopag: Study patients will be provided eltrombopag to raise platelet levels before anti-hepatitis C drugs are initiated, and will continue eltrombopag throughout the study.
|
|---|---|
|
Percentage of Study Patients Completing Antiviral Therapy, as Per Boceprevir Prescribing Guidelines.
|
1 Participants
|
Adverse Events
Thrombocytopenic (Low Platelet) Patients
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Thrombocytopenic (Low Platelet) Patients
n=7 participants at risk
All study patients will undergo intervention in this study.
The intervention will be a lead-in with eltrombopag and antiviral triple therapy (interferon, ribavirin and boceprevir).
Eltrombopag: Study patients will be provided eltrombopag to raise platelet levels before anti-hepatitis C drugs are initiated, and will continue eltrombopag throughout the study.
One subject completed the study as planned. Four subjects had to drop out of the study early for different reasons. One subject was not able to start the hepatitis C triple therapy medications due to a medical condition, two subjects discontinued due to lack of virologic response and one subject discontinued treatment due to side effects.
|
|---|---|
|
Gastrointestinal disorders
Variceal hemorrhage
|
14.3%
1/7 • Number of events 1 • 24 months
No unusual collection of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
14.3%
1/7 • Number of events 1 • 24 months
No unusual collection of adverse events.
|
|
Nervous system disorders
Flu like symptoms
|
14.3%
1/7 • Number of events 1 • 24 months
No unusual collection of adverse events.
|
Additional Information
William M Lee, MD
UT Southwestern Medical Center at Dallas
Phone: 214 645 6111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place