Trial Outcomes & Findings for Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia (NCT NCT02825212)
NCT ID: NCT02825212
Last Updated: 2020-12-17
Results Overview
Number of participants who attain SVR, ie, cleared HCV
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
10 participants
Primary outcome timeframe
2-4 weeks and 24 weeks after treatment
Results posted on
2020-12-17
Participant Flow
Participants were self referred after discussion with their physicians, enrolled sequentially over a two year period (2016-2018)
Long recruitment, with part of the problem of finding patients not already on antivirals. The original protocol was for Harvoni, which had been specifically licensed for Hepatitis C Virus genotype 1. Protocol was modified after discussion with Gilead with the licensing of Epclusa, which is active for other genotypes, specifically to be able to include two patients with genotype 2 thus enabling the study to reach full enrollment. Study objective is not to compare medications.
Participant milestones
| Measure |
Pts With Hep C Virus Infection-Related Cryoglobulinemia
Participants with Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia who were treated with antivirals.
Antivirals were either Harvoni or Epclusa. Ledipasvir/Sofosbuvir (Harvoni) 90mg/400 mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with compensated cirrhosis) for genotype 1 .
Sofosbuvir/Velpatasvir (Epclusa) 400mg/100mg 400mg/100mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced or treatment experienced subjects with compensated cirrhosis) for genotype 1-6 subjects.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia
Baseline characteristics by cohort
| Measure |
Pts With Hep C Virus Infection-Related Cryoglobulinemia
n=10 Participants
Participants with Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia who were treated with antivirals.
Antivirals were either Harvoni or Epclusa. Ledipasvir/Sofosbuvir (Harvoni) 90mg/400 mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with compensated cirrhosis) for genotype 1 .
Sofosbuvir/Velpatasvir (Epclusa) 400mg/100mg 400mg/100mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced or treatment experienced subjects with compensated cirrhosis) for genotype 1-6 subjects.
|
|---|---|
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Age, Continuous
|
60.5 years
STANDARD_DEVIATION 14.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
5 Participants
n=5 Participants
|
|
Years Since HCV Diagnosis
|
16.1 years
STANDARD_DEVIATION 12.29 • n=5 Participants
|
|
Treatment Naive
|
3 Participants
n=5 Participants
|
|
Cirrhosis
|
2 Participants
n=5 Participants
|
|
AST levels
|
74.7 U/L
STANDARD_DEVIATION 99.41 • n=5 Participants
|
|
Platelets level
|
192.7 K/uL
STANDARD_DEVIATION 73.96 • n=5 Participants
|
|
HCV genotype
1a
|
3 Participants
n=5 Participants
|
|
HCV genotype
1b
|
5 Participants
n=5 Participants
|
|
HCV genotype
2
|
1 Participants
n=5 Participants
|
|
HCV genotype
2a
|
1 Participants
n=5 Participants
|
|
Bilirubin
|
0.93 mg/dL
STANDARD_DEVIATION 1.66 • n=5 Participants
|
|
Viral Count
|
78.98 IU/ml
STANDARD_DEVIATION 136.72 • n=5 Participants
|
|
Hepa Score for Fibrosis
F0-F1
|
2 Participants
n=5 Participants
|
|
Hepa Score for Fibrosis
F1
|
1 Participants
n=5 Participants
|
|
Hepa Score for Fibrosis
F1-F2
|
1 Participants
n=5 Participants
|
|
Hepa Score for Fibrosis
F2
|
1 Participants
n=5 Participants
|
|
Hepa Score for Fibrosis
F2-F4
|
1 Participants
n=5 Participants
|
|
Hepa Score for Fibrosis
F3
|
3 Participants
n=5 Participants
|
|
Hepa Score for Fibrosis
F4
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-4 weeks and 24 weeks after treatmentNumber of participants who attain SVR, ie, cleared HCV
Outcome measures
| Measure |
Pts With Hep C Virus Infection-Related Cryoglobulinemia
n=10 Participants
Participants with Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia who were treated with antivirals.
Antivirals were either Harvoni or Epclusa. Ledipasvir/Sofosbuvir (Harvoni) 90mg/400 mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with compensated cirrhosis) for genotype 1 .
Sofosbuvir/Velpatasvir (Epclusa) 400mg/100mg 400mg/100mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced or treatment experienced subjects with compensated cirrhosis) for genotype 1-6 subjects.
|
|---|---|
|
Sustained Virologic Response (SVR)
2-4 weeks after treatment
|
10 Participants
|
|
Sustained Virologic Response (SVR)
24 weeks after treatment
|
10 Participants
|
PRIMARY outcome
Timeframe: up to 24 weeks after treatmentResponse to medication in patients with MC categorized as either complete response (100% response) vs partial response (50% response).
Outcome measures
| Measure |
Pts With Hep C Virus Infection-Related Cryoglobulinemia
n=10 Participants
Participants with Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia who were treated with antivirals.
Antivirals were either Harvoni or Epclusa. Ledipasvir/Sofosbuvir (Harvoni) 90mg/400 mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with compensated cirrhosis) for genotype 1 .
Sofosbuvir/Velpatasvir (Epclusa) 400mg/100mg 400mg/100mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced or treatment experienced subjects with compensated cirrhosis) for genotype 1-6 subjects.
|
|---|---|
|
Response in Patients With Mixed Cryoglobulinemia (MC)
Partial Response
|
9 Participants
|
|
Response in Patients With Mixed Cryoglobulinemia (MC)
Complete Response
|
0 Participants
|
|
Response in Patients With Mixed Cryoglobulinemia (MC)
No Response
|
1 Participants
|
Adverse Events
Pts With Hep C Virus Infection-Related Cryoglobulinemia
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pts With Hep C Virus Infection-Related Cryoglobulinemia
n=10 participants at risk
Participants with Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia who were treated with antivirals.
Antivirals were either Harvoni or Epclusa. Ledipasvir/Sofosbuvir (Harvoni) 90mg/400 mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with compensated cirrhosis) for genotype 1 .
Sofosbuvir/Velpatasvir (Epclusa) 400mg/100mg 400mg/100mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced or treatment experienced subjects with compensated cirrhosis) for genotype 1-6 subjects.
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|---|---|
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Nervous system disorders
Herpes Zoster
|
10.0%
1/10 • up to 24 weeks after treatment
|
Other adverse events
| Measure |
Pts With Hep C Virus Infection-Related Cryoglobulinemia
n=10 participants at risk
Participants with Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia who were treated with antivirals.
Antivirals were either Harvoni or Epclusa. Ledipasvir/Sofosbuvir (Harvoni) 90mg/400 mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with compensated cirrhosis) for genotype 1 .
Sofosbuvir/Velpatasvir (Epclusa) 400mg/100mg 400mg/100mg FDC once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced or treatment experienced subjects with compensated cirrhosis) for genotype 1-6 subjects.
|
|---|---|
|
General disorders
Increased fatigue
|
40.0%
4/10 • up to 24 weeks after treatment
|
|
Gastrointestinal disorders
nausea and abdominal pain
|
30.0%
3/10 • up to 24 weeks after treatment
|
|
Renal and urinary disorders
Urinary frequency and/or dysuria
|
20.0%
2/10 • up to 24 weeks after treatment
|
Additional Information
Dr. Peter D. Gorevic
Icahn School of Medicine at Mount Sinai
Phone: 212-241-0968
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place