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NCT02825212 · ClinicalTrials.gov registry record · Phase 2

Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia

A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
Phase 2
Development phase
10
Enrollment target

NCT02825212: Completed Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT02825212 is a Phase 2 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02825212, a Phase 2 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

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.

Primary Outcome

Number of participants who attain SVR, ie, cleared HCV

Interventions

  • DRUG Epclusa
  • DRUG Harvoni

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2016-02
Est. Completion 2019-07-19
Phase Phase 2

What the finished NCT02825212 record still lists

NCT02825212 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Epclusa is the first listed.

NCT02825212 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02825212 about?

NCT02825212 is a clinical study titled "Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia". 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 researche...

What is the current status of trial NCT02825212?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2016-02. Estimated completion is 2019-07-19.

What interventions are being tested in trial NCT02825212?

The interventions under investigation include: Epclusa (DRUG), Harvoni (DRUG).

Who is sponsoring clinical trial NCT02825212?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02825212's enrollment target sits among peer trials

10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02825212, the US trial registry maintained by the National Library of Medicine. NCT02825212 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.