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Trial record 83 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study (Optimal)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717949
Recruitment Status : Terminated (failure to recruit)
First Posted : March 24, 2016
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Liver Disease
Interventions Drug: sofosbuvir/ledipasvir
Drug: sofosbuvir
Drug: Ribavirin
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sofosbuvir/Ledipasvir Sofosbuvir and Ribavirin
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started [1] 0 0
Completed 0 0
Not Completed 0 0
[1]
data not reported due to confidentiality
Arm/Group Title Sofosbuvir and Ribavirin Sofosbuvir/Ledipasvir Total
Hide Arm/Group Description

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.

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

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
no patients were analyzed due to insufficient numbers and risk of identifying patient by reporting data on 1 person
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
Race (NIH/OMB)  
Number Analyzed 0 participants 0 participants 0 participants
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 0 participants
1.Primary Outcome
Title Number Subjects Who Experience Adverse Events on HCV Treatment as Assessed by Division of AIDS (DAIDS) Adverse Event (AE) Grading Table Version 2.0.
Hide Description number of subjects who experience treatment-related adverse event on HCV treatment as assessed by DAIDS AE Grading Table version 2.
Time Frame from drug dispensation until post-treatment week 36
Hide Outcome Measure Data
Hide Analysis Population Description
data not reported due to confidentiality
Arm/Group Title Sofosbuvir/Ledipasvir Sofosbuvir and Ribavirin
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Subjects Who Have a Change in Lymph Node Size From Baseline After HCV Treatment
Hide Description Number of subjects who have a change in the size of lymph node size from baseline
Time Frame from baseline to post-treament week 36
Hide Outcome Measure Data
Hide Analysis Population Description
data not reported due to confidentiality
Arm/Group Title Sofosbuvir and Ribavirin Sofosbuvir/Ledipasvir
Hide Arm/Group Description:

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.

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description data not reported due to confidentiality
 
Arm/Group Title Sofosbuvir/Ledipasvir Sofosbuvir and Ribavirin
Hide Arm/Group Description

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 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.

All-Cause Mortality
Sofosbuvir/Ledipasvir Sofosbuvir and Ribavirin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Sofosbuvir/Ledipasvir Sofosbuvir and Ribavirin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sofosbuvir/Ledipasvir Sofosbuvir and Ribavirin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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: Mamta K.Jain, MD
Organization: UT Southwestern Medical Center
Phone: 214-648-9914
EMail: mamta.jain@utsouthwestern.edu
Publications:
Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02717949     History of Changes
Other Study ID Numbers: 042015-086
First Submitted: November 10, 2015
First Posted: March 24, 2016
Results First Submitted: October 29, 2018
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019