Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia
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|ClinicalTrials.gov Identifier: NCT02825212|
Recruitment Status : Completed
First Posted : July 7, 2016
Results First Posted : December 17, 2020
Last Update Posted : December 17, 2020
10 patients with chronic genotype 1 HCV infection and mixed cryoglobulinemia will be treated with Ledipasvir/Sofosbuvir 90mg/400 mg FDC once daily for 12 weeks (naïve subjects or non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with cirrhosis).
The researchers anticipate that approximately 20% of subjects may have cirrhosis.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Cryoglobulinemia||Drug: Harvoni Drug: Epclusa||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||July 19, 2019|
|Actual Study Completion Date :||July 19, 2019|
Experimental: Participant with Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia
Participants treated with either Harvoni or Epclusa
12 weeks for naïve subjects or non-cirrhotic treatment experienced subjects; or 24 weeks for treatment experienced subjects with cirrhosis
once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced or treatment experienced subjects with compensated cirrhosis) for genotype 1-6 subjects.
Other Name: Sofosbuvir/Velpatasvir
- Sustained Virologic Response (SVR) [ Time Frame: 2-4 weeks and 24 weeks after treatment ]Number of participants who attain SVR, ie, cleared HCV
- Response in Patients With Mixed Cryoglobulinemia (MC) [ Time Frame: up to 24 weeks after treatment ]Response to medication in patients with MC categorized as either complete response (100% response) vs partial response (50% response).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825212
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Peter Gorevic, MD||Icahn School of Medicine at Mount Sinai|