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Direct-acting Antiviral
Cohort 1: Adult Formulation; 12 to < 18 years for Hepatitis C (DORA Trial)
Phase 2 & 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hepatitis C virus (HCV) infection demonstrated by positive anti-HCV antibody (Ab) and HCV ribonucleic acid (RNA) greater than or equal to 1000 International Unit (IU)/mL
Subjects participating in the intense pharmacokinetic (IPK) part must have been HCV treatment-naive, with or without compensated cirrhosis (Child-Pugh A), human immunodeficiency virus type 1 (HIV-1) negative and must have had a Screening laboratory result indicating HCV genotype (GT) 1, 2, 3, 4, 5, or 6-infection.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after last dose of study drug (week 20, 24, or 28 depending on treatment duration)
Awards & highlights
DORA Trial Summary
This trial is studying a glecaprevir and pibrentasvir combination in treating patients with hepatitis C. The study is divided into two parts, one for adolescents willing to swallow the adult formulation and one for pediatric patients who received the pediatric formulation. Data are presented for all participants who completed post-treatment Week 12 or prematurely discontinued from the study.
Eligible Conditions
- Hepatitis C
DORA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have tested positive for HCV Ab and RNA levels of at least 1000 IU/mL.
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To participate in the IPK part, you must have been HCV treatment-unexperienced with or without compensated cirrhosis (Child-Pugh A), HIV-1 negative and your Screening laboratory result should indicate an infection of HCV genotype 1, 2, 3, 4, 5 or 6.
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You have a confirmed Hepatitis C virus (HCV) infection, evidenced by positive anti-HCV antibody (Ab) and HCV Ribonucleic acid (RNA) levels greater than 1000 IU/ mL.
DORA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks after the last dose of study drug (week 20, 24, or 28 depending on treatment duration)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks after the last dose of study drug (week 20, 24, or 28 depending on treatment duration)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Steady-state AUC0-24 of Pibrentasvir
Steady-state Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of Glecaprevir
Secondary outcome measures
Apparent Clearance (CL/F) of Glecaprevir From Plasma
Apparent Clearance of Pibrentasvir From Plasma
Maximum Plasma Concentration (Cmax) of Glecaprevir
+10 moreDORA Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4: Pediatric Formulation; 3 to < 6 yearsExperimental Treatment1 Intervention
Children aged 3 to < 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.
The initial proposed dose for children 3 to < 6 years old (12 to < 20 kg) was GLE 120 mg + PIB 45 mg. After PK analysis from the first 5 enrolled participants the dose was adjusted to GLE 150 mg + PIB 60 mg.
Group II: Cohort 3: Pediatric Formulation; 6 to < 9 yearsExperimental Treatment1 Intervention
Children aged 6 to < 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.
The initial proposed dose for children 6 to < 9 years old (20 to < 30 kg) was GLE 160 mg + PIB 60 mg. After PK analysis from the first 6 enrolled participants the dose was adjusted to GLE 200 mg + PIB 80 mg.
Group III: Cohort 2: Pediatric Formulation; 9 to < 12 yearsExperimental Treatment1 Intervention
Children aged 9 to < 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.
The initial proposed dose for children 9 to < 12 years old (30 to < 45 kg) was GLE 200 mg + PIB 75 mg. After PK analysis from the first 6 enrolled participants the dose was adjusted to GLE 250 mg + PIB 100 mg.
Group IV: Cohort 1: Adult Formulation; 12 to < 18 yearsExperimental Treatment1 Intervention
Adolescents aged 12 to < 18 years old received the adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 100 mg/ 40 mg co-formulated film-coated tablets for a once daily (QD) total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glecaprevir/Pibrentasvir Adult Formulation
2017
Completed Phase 3
~130
Glecaprevir + Pibrentasvir Pediatric Formulation
2017
Completed Phase 3
~130
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
946 Previous Clinical Trials
496,343 Total Patients Enrolled
110 Trials studying Hepatitis C
32,700 Patients Enrolled for Hepatitis C
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,428 Total Patients Enrolled
37 Trials studying Hepatitis C
14,191 Patients Enrolled for Hepatitis C
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Baylor College of Medicine /ID# 157989
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
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