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Antiviral

Harvoni for Porphyria Cutanea Tarda

Phase 2
Waitlist Available
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will test whether Harvoni is an effective treatment for patients with Chronic Hepatitis C and active PCT.

Eligible Conditions
  • Porphyria Cutanea Tarda
  • Hepatitis C

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Resolution of Active PCT by 7 Months After Start of Therapy
Secondary outcome measures
Number of Participants With Complete Biochemical Remission of PCT
Number of Participants With Cure of CHC
Time to Resolution of Active PCT

Side effects data

From 2019 Phase 4 trial • 68 Patients • NCT02533934
7%
Hospitalization (Unknown)
7%
Pneumonia
5%
esophagogastroduodendoscopy
2%
Polysubstance use
2%
Seizure
2%
Hyperglycemic seizure
2%
Neck femur fracture
2%
Ventral hernia
2%
Bronchitis
2%
Pnemonia
2%
pruritus
2%
Hyperbilirubiinemia
2%
Hyperglycemia
2%
Kidney stone
2%
Gout
2%
Acute Kidney Injury
2%
Dyspnea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adults With HIV and Chronic HCV and End-stage Liver Disease (ESLD) Pre-liver Transplant
Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant

Trial Design

1Treatment groups
Experimental Treatment
Group I: HarvoniExperimental Treatment1 Intervention
1 tablet per day, oral, taken with or without food. 8 weeks for patients without cirrhosis, not previously treated with HCV GT1 and HCV rNA < 6 million IU/mL; 12 weeks for patients without cirrhosis; 24 weeks for patients with compensated cirrhosis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Harvoni
2016
Completed Phase 4
~3400

Find a Location

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor
1,082 Previous Clinical Trials
842,818 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,690 Previous Clinical Trials
6,950,963 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,237 Previous Clinical Trials
1,002,974 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Harvoni Treatment Porphyria Cutanea Tarda
2017. "Harvoni Treatment Porphyria Cutanea Tarda". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03118674.
~3 spots leftby Apr 2025
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