Trial Outcomes & Findings for Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis (NCT NCT02455167)
NCT ID: NCT02455167
Last Updated: 2021-09-13
Results Overview
Number of participants who cleared Hepatitis C (HCV) after 12 weeks was collected (HCV RNA level was "Not Detected".
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
9 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-09-13
Participant Flow
5 participants screen-failed after enrollment.
Participant milestones
| Measure |
HCV Positive Group
A single arm study of 'Simeprivir (SMV), Sofosbuvir (SOF) and Ribavirin (RBV) in an HCV positive population.
Simeprivir (SMV): Experimental Single arm study. All participants will get the same treatment.
Sofosbuvir (SOF): Experimental Single arm study. All participants will get the same treatment.
Ribavirin (RBV): Experimental Single arm study. All participants will get the same treatment.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis
Baseline characteristics by cohort
| Measure |
HCV Positive Group
n=4 Participants
A single arm study of 'Simeprivir (SMV), Sofosbuvir (SOF) and Ribavirin (RBV) in an HCV positive population.
Simeprivir (SMV): Experimental Single arm study. All participants will get the same treatment.
Sofosbuvir (SOF): Experimental Single arm study. All participants will get the same treatment.
Ribavirin (RBV): Experimental Single arm study. All participants will get the same treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksNumber of participants who cleared Hepatitis C (HCV) after 12 weeks was collected (HCV RNA level was "Not Detected".
Outcome measures
| Measure |
HCV Positive Group
n=4 Participants
A single arm study of 'Simeprivir (SMV), Sofosbuvir (SOF) and Ribavirin (RBV) in an HCV positive population.
Simeprivir (SMV): Experimental Single arm study. All participants will get the same treatment.
Sofosbuvir (SOF): Experimental Single arm study. All participants will get the same treatment.
Ribavirin (RBV): Experimental Single arm study. All participants will get the same treatment.
|
|---|---|
|
The Sustained Virologic Response (SVR) in Patients Infected With HCV Genotype 1, Cirrhosis, and Early Clinical Decompensation
|
4 Participants
|
PRIMARY outcome
Timeframe: BaselineLiver function as assessed via MELD score. The Model For End-Stage Liver Disease (MELD) score assesses the severity of patient liver disease. Possible scores range from 6 to 40, with higher scores indicating more severe liver disease and a worse outcome.
Outcome measures
| Measure |
HCV Positive Group
n=4 Participants
A single arm study of 'Simeprivir (SMV), Sofosbuvir (SOF) and Ribavirin (RBV) in an HCV positive population.
Simeprivir (SMV): Experimental Single arm study. All participants will get the same treatment.
Sofosbuvir (SOF): Experimental Single arm study. All participants will get the same treatment.
Ribavirin (RBV): Experimental Single arm study. All participants will get the same treatment.
|
|---|---|
|
Hepatic Improvement During and After Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) Treatment Using a New Test of Liver Function, HepQuant-SHUNT: Baseline
|
8 score on a scale
Interval 7.0 to 10.0
|
PRIMARY outcome
Timeframe: 12 WeeksLiver function as assessed via MELD score. The Model For End-Stage Liver Disease (MELD) score assesses the severity of patient liver disease. Possible scores range from 6 to 40, with higher scores indicating more severe liver disease and a worse outcome.
Outcome measures
| Measure |
HCV Positive Group
n=4 Participants
A single arm study of 'Simeprivir (SMV), Sofosbuvir (SOF) and Ribavirin (RBV) in an HCV positive population.
Simeprivir (SMV): Experimental Single arm study. All participants will get the same treatment.
Sofosbuvir (SOF): Experimental Single arm study. All participants will get the same treatment.
Ribavirin (RBV): Experimental Single arm study. All participants will get the same treatment.
|
|---|---|
|
Hepatic Improvement During and After Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) Treatment Using a New Test of Liver Function, HepQuant-SHUNT: 12 Weeks
|
7.25 score on a scale
Interval 7.0 to 8.0
|
Adverse Events
HCV Positive Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HCV Positive Group
n=4 participants at risk
A single arm study of 'Simeprivir (SMV), Sofosbuvir (SOF) and Ribavirin (RBV) in an HCV positive population.
Simeprivir (SMV): Experimental Single arm study. All participants will get the same treatment.
Sofosbuvir (SOF): Experimental Single arm study. All participants will get the same treatment.
Ribavirin (RBV): Experimental Single arm study. All participants will get the same treatment.
|
|---|---|
|
Investigations
Protocol deviation
|
25.0%
1/4 • Number of events 1 • 12 Weeks
|
Additional Information
Amanda Wieland, MD
University of Colorado Denver | Anschutz
Phone: 3037241111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place