Trial Outcomes & Findings for Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study (NCT NCT02717949)
NCT ID: NCT02717949
Last Updated: 2019-01-08
Results Overview
number of subjects who experience treatment-related adverse event on HCV treatment as assessed by DAIDS AE Grading Table version 2.
TERMINATED
PHASE4
1 participants
from drug dispensation until post-treatment week 36
2019-01-08
Participant Flow
Participant milestones
| Measure |
Sofosbuvir/Ledipasvir
sofosbuvir and ledipasvir fixed dose combination given orally once a day for genotype 1 and 4.
sofosbuvir/ledipasvir: sofosbuvir ledipasvir fixed dose combination given once a day by mouth
|
Sofosbuvir and Ribavirin
Sofosbuvir 400 mg given orally once a day with weight-base ribavirin of 1200 mg for those \>75 kg and 1000 mg for those \<75kg given in divided dose twice a day. This intervention is for genotype 2 and 3
sofosbuvir: sofosbuvir 400 mg given one a daily orally and weight-based ribavirin given twice a day orally
Ribavirin: ribavirin 1200 mg given orally in divided dose for those \>75kg and 1000 mg in divided dose for those \<75 kg.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: from drug dispensation until post-treatment week 36Population: data not reported due to confidentiality
number of subjects who experience treatment-related adverse event on HCV treatment as assessed by DAIDS AE Grading Table version 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to post-treament week 36Population: data not reported due to confidentiality
Number of subjects who have a change in the size of lymph node size from baseline
Outcome measures
Outcome data not reported
Adverse Events
Sofosbuvir/Ledipasvir
Sofosbuvir and Ribavirin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place