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Hepatitis C Virus (HCV)Phase 2/3DORANCT03067129

A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection

A Phase 2/3 study testing Glecaprevir/Pibrentasvir Adult Formulation and Glecaprevir + Pibrentasvir Pediatric Formulation in people with Hepatitis C Virus (HCV), run by AbbVie at 38 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in children ages 3 to < 12 years. Read more about this study

Who is it for?
Ages 3 to 17 years
Conditions the study is for
Hepatitis C Virus (HCV)
What is being tested?
Glecaprevir/Pibrentasvir Adult Formulation and Glecaprevir + Pibrentasvir Pediatric Formulation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
38 sitesin 9 countries
Study dates
20 Mar 2017to 12 Sep 2022
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Females who were pregnant or breastfeeding
  • Positive test result for hepatitis B surface antigen (HbsAg) or positive test result for hepatitis B virus deoxyribonucleic acid (DNA)
  • Participants with other known liver diseases
  • Decompensated cirrhosis defined as: presence of ascites, history of variceal bleeding, lab values consistent with Child-Pugh class B or C cirrhosis

Trial locations and contacts

38 sites in 9 countries.

38 sites in 9 countries

United States15 sites

  • Childrens Hospital Colorado /ID# 157996

    Aurora, Colorado, 80045

  • Boston Childrens Hospital /ID# 157988

    Boston, Massachusetts, 02115

  • Boston Medical Center /ID# 157997

    Boston, Massachusetts, 02118

  • UNC Health Care /ID# 157991

    Chapel Hill, North Carolina, 27514

  • Cincinnati Childrens Hosp Med /ID# 158007

    Cincinnati, Ohio, 45229

  • UF Hepatology Research at CTRB /ID# 158008

    Gainesville, Florida, 32610-0272

  • CT Childrens Medical Ctr, US /ID# 158639

    Hartford, Connecticut, 06106

  • Baylor College of Medicine /ID# 157989

    Houston, Texas, 77030-3411

  • Indiana University /ID# 158001

    Indianapolis, Indiana, 46202

  • Monroe-Carell Jr. Children's H /ID# 169037

    Nashville, Tennessee, 37232

  • Columbia Univ Medical Center /ID# 158000

    New York, New York, 10032-3725

  • Advent Health /ID# 166022

    Orlando, Florida, 32803

  • Children's Hospital of Philadelphia /ID# 158003

    Philadelphia, Pennsylvania, 19104

  • Child Hosp of Pittsburgh,PA /ID# 158004

    Pittsburgh, Pennsylvania, 15213-2583

  • Univ of California San Francis /ID# 158002

    San Francisco, California, 94158

Other trials in United States

Japan4 sites

  • Juntendo University Hospital /ID# 212912

    Bunkyo-ku, Tokyo, 113-8431

  • Kurume University Hospital /ID# 165718

    Kurume-shi, Fukuoka, 830-0011

  • Osaka General Medical Center /ID# 212745

    Osaka, Osaka, 558-8558

  • Osaka University Hospital /ID# 165709

    Suita-shi, Osaka, 565-0871

Other trials in Japan

Spain4 sites

  • Hospital Universitario Vall d'Hebron /ID# 163323

    Barcelona, 08035

  • Hospital Sant Joan de Deu /ID# 163282

    Esplugues de Llobregat, Barcelona, 08950

  • Hospital Universitario La Paz /ID# 163283

    Madrid, 28046

  • Hospital Universitario y Politecnico La Fe /ID# 163325

    Valencia, 46026

Other trials in Spain

Canada3 sites

  • Alberta Children's Hospital /ID# 163449

    Calgary, Alberta, T3B 6A9

  • Stollery Children's Hospital /ID# 163450

    Edmonton, Alberta, T6G 2X8

  • Hospital for Sick Children /ID# 163448

    Toronto, Ontario, M5G 1X8

Other trials in Canada

Germany3 sites

  • Charite Universitaetsmedizin Berlin /ID# 165186

    Berlin, 10117

  • Universitatsklinikum Freiburg /ID# 165187

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Helios Klinikum Wuppertal /ID# 165185

    Wuppertal, 42283

Other trials in Germany

Russia3 sites

  • Federal State Budgetary Institution - Institute of Nutrition /ID# 163345

    Moscow, Moscow, 109240

  • National Medical Scientific Centre of children health /ID# 163344

    Moscow, Moscow, 119296

  • Scientific and Research Institute of pediatric infections /ID# 163343

    Saint Petersburg, 197022

Other trials in Russia

United Kingdom3 sites

  • Birmingham Childrens Hospital /ID# 162718

    Birmingham, B4 6NH

  • Queen Elizabeth University Hos /ID# 162719

    Glasgow, G514TF

  • King's College Hospital NHS /ID# 162717

    London, SE5 9RS

Other trials in United Kingdom

Belgium2 sites

  • UZ Leuven /ID# 162174

    Leuven, 3000

  • Cliniques Universitaires Saint Luc /ID# 162173

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Puerto Rico1 site

  • San Jorge Children Hospital /ID# 160850

    San Juan, 00912-3310

Other trials in Puerto Rico

About this study

Official title: An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection

The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in children ages 3 to < 12 years.

Read the detailed description

This was a multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of glecaprevir (GLE) and pibrentasvir (PIB) treatment for 8, 12, or 16 weeks in hepatitis C virus (HCV) genotype 1 - 6 (GT1 - GT6)-infected pediatric participants 3 to < 18 years of age, with or without compensated cirrhosis, with or without human immunodeficiency virus (HIV) coinfection, who are either treatment-naïve (TN), treatment-experienced (TE) with pegylated interferon (pegIFN) with or without ribavirin (RBV), or TE with sofosbuvir (SOF) + RBV with or without pegIFN.

The study was divided into 2 parts, according to the formulation of GLE/PIB administered. Part 1 of the study enrolled HCV GT1 - GT6 infected adolescent participants into the 12 to < 18 years old age group who were willing to swallow the adult formulation of GLE/PIB (Cohort 1). Part 2 of the study enrolled HCV GT1 - GT6 infected pediatric participants divided into the 9 to < 12 (Cohort 2), 6 to < 9 (Cohort 3), and 3 to < 6 (Cohort 4) years old age groups, to receive the pediatric formulation of GLE + PIB. Part 1 enrolled first and once the pediatric formulation was available enrollment into Part 2 commenced, with each cohort enrolled in parallel.

In each cohort, the first group of participants were enrolled into an intense pharmacokinetics (IPK) portion to characterize the PK and safety in each age group, followed by enrollment into a non-IPK safety/efficacy portion. Study participants enrolled in the IPK portion must have been HIV-negative, treatment-naive, and have an identified HCV genotype. In the IPK portion the first approximately six participants received an initial proposed dose of GLE and PIB based on the child's weight and age at screening. PK samples from these participants were evaluated to determine if therapeutic efficacious exposures were attained, comparable to those of adults, and if any dose adjustments were needed. After the intensive PK analysis results for the first six participants were available, enrollment of the remaining IPK portion resumed with subsequent participants receiving an adjusted final dose as applicable. Additional participants may have been required for further intensive PK analysis per age cohort if therapeutic exposure targets were not achieved.

Enrollment into the non-IPK safety and efficacy portions began when the dosing recommendations per age group based on the PK and clinical data from the IPK analysis were ascertained.

Being tested
Glecaprevir/Pibrentasvir Adult Formulation, Glecaprevir + Pibrentasvir Pediatric Formulation
Keywords
Chronic Hepatitis C Virus, Glecaprevir, Pibrentasvir, Pharmacokinetic, Treatment naïve, Treatment experienced, Interferon (IFN), Pegylated interferon (pegIFN), Ribavirin (RBV), Sofosbuvir, Non-cirrhotic cirrhosis, Compensated (Child-Pugh A) cirrhosis
Medical subject headings
Hepatitis C, Hepatitis C, Chronic, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glecaprevir/Pibrentasvir Adult FormulationDrug

    Also called ABT-493/ABT-530, MAVYRET®

    Co-formulated film-coated tablet (100 mg/40 mg)

  • Glecaprevir + Pibrentasvir Pediatric FormulationDrug

    Also called ABT-493/ABT-530

    Film-coated pellets/granules (15.67%/8.25%) administered by mixing with a small amount (1-2 teaspoons) of a soft food vehicle, such as hazelnut spread, Greek yogurt, or peanut butter.

Study groups in NCT03067129
Study groupRoleWhat they receive
Cohort 1: Adult Formulation; 12 to < 18 yearsExperimentalAdolescents 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.
Receives: Drug: Glecaprevir/Pibrentasvir Adult Formulation
Cohort 2: Pediatric Formulation; 9 to < 12 yearsExperimentalChildren 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.
Receives: Drug: Glecaprevir + Pibrentasvir Pediatric Formulation
Cohort 3: Pediatric Formulation; 6 to < 9 yearsExperimentalChildren 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.
Receives: Drug: Glecaprevir + Pibrentasvir Pediatric Formulation
Cohort 4: Pediatric Formulation; 3 to < 6 yearsExperimentalChildren 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.
Receives: Drug: Glecaprevir + Pibrentasvir Pediatric Formulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Steady-state Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of Glecaprevir

    The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in blood plasma. The steady-state exposure of GLE was measured up to 24 hours after dosing at Week 2 and estimated using non-compartmental analysis.

    Measured: Week 2 from predose to 24 hours post-dose

  2. Steady-state AUC0-24 of Pibrentasvir

    The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in blood plasma. The steady-state exposure of PIB was measured up to 24 hours after dosing at Week 2 and estimated using non-compartmental analysis.

    Measured: Week 2 from predose to 24 hours post-dose

  3. Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12)

    SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last actual dose of study drug. Plasma HCV RNA levels were collected using the COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test v2.0.

    SVR12 was considered a primary efficacy endpoint by the United States (US) regulatory agency and was considered secondary outside of the US.

    Measured: 12 weeks after last dose of study drug (Week 20, 24, or 28 depending on treatment duration)

Secondary outcomes (13)

  1. Maximum Plasma Concentration (Cmax) of Glecaprevir

    Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administered and before administration of a second dose.

    Measured: Week 2 from predose to 24 hours post-dose

  2. Apparent Clearance (CL/F) of Glecaprevir From Plasma

    CL/F is a quantitative measure of the rate at which a drug substance is removed from the body. It was estimated by non-compartmental pharmacokinetic analysis.

    Measured: Week 2 from predose to 24 hours post-dose

  3. Maximum Plasma Concentration of Pibrentasvir

    Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administered and before administration of a second dose.

    Measured: Week 2 from predose to 24 hours post-dose

  4. Apparent Clearance of Pibrentasvir From Plasma

    CL/F is a quantitative measure of the rate at which a drug substance is removed from the body. It was estimated by non-compartmental pharmacokinetic analysis.

    Measured: Week 2 from predose to 24 hours post-dose

  5. Percentage of Participants Who Experienced On-treatment Virologic Failure

    On-treatment virologic failure is defined as meeting one of the following:

    • A confirmed (defined as two consecutive HCV RNA measurements) increase of > 1 log₁₀ IU/mL above nadir during treatment;
    • Confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < 15 IU/mL during treatment;
    • HCV RNA ≥ 15 IU/mL at the end of treatment with at least 6 weeks of treatment.

    Measured: Up to Week 8, 12, or 16 (depending on treatment duration)

  6. Percentage of Participants With Post-treatment Relapse up to 12 Weeks Post Treatment

    Post-treatment relapse is defined as confirmed HCV RNA ≥ 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < 15 IU/mL at the end of treatment; excluding participants who had been shown to be re-infected.

    Measured: Up to 12 weeks after the last dose of study drug (Week 20, 24, or 28 depending on treatment duration)

  7. Percentage of Participants With New Hepatitis C Virus Infection (Reinfection)

    Reinfection is defined as confirmed HCV RNA ≥ 15 IU/mL in the post-treatment period in a participant who had HCV RNA < 15 IU/mL at the Final Treatment Visit, along with post-treatment detection of a different HCV genotype, subtype, or clade compared with Baseline, as determined by phylogenetic analysis of the nonstructural viral protein 3 (NS3) or NS5A, and/or NS5B gene sequences.

    Measured: From the end of treatment up to post-treatment Week 144

  8. Palatability Questionnaire Question 1: How Convenient or Inconvenient Was it to Prepare the Dose?

    For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE + PIB formulation.

    Question 1 "How Convenient or Inconvenient Was it to Prepare the Dose?" was answered as "very convenient", "convenient", "borderline", "inconvenient", or "very inconvenient".

    Measured: Final treatment visit (up to Week 8, 12, or 16, depending on treatment duration)

  9. Palatability Questionnaire Question 2: How Long Did it Typically Take for the Child to Take the Dose?

    For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE + PIB formulation.

    Question 2 "How Long Did it Typically Take for the Child to Take the Dose?" was answered as "5 minutes or less", "5 to 15 minutes", "15 to 30 minutes", or "more than 30 minutes".

    Measured: Final treatment visit (up to Week 8, 12, or 16, depending on duration of treatment)

  10. Palatability Questionnaire Question 3: Were You Able to Successfully Administer the Whole Dose to the Child With 1 to 2 Teaspoons (5 to 10 mL) of Soft Food?

    For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE + PIB formulation.

    Question 3 "Were You Able to Successfully Administer the Whole Dose to the Child With 1 to 2 Teaspoons (5 to 10 mL) of Soft Food?" was answered as "Yes" or "No".

    Measured: Final treatment visit (up to Week 8, 12, or 16, depending on treatment duration)

  11. Palatability Questionnaire Question 4: Did You Experience Any Resistance When Feeding the Child the Medicine?

    For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE + PIB formulation. Question 4 "Did You Experience Any Resistance When Feeding the Child the Medicine?" was answered as "Yes" or "No".

    Measured: Final treatment visit (up to Week 8, 12, or 16 depending on treatment duration)

  12. Palatability Questionnaire Question 4a: Type of Feeding Resistance

    For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE + PIB formulation. Question 4a "Type of feeding resistance?" tracks feeding resistance experienced at any time during treatment, and was answered as "Did not like taste of medicine", "Did not like texture of medicine", "Did not like the soft food used", "Did not like to swallow the amount of medicine", or "Unrelated to the medicine".

    Measured: Up to final treatment visit (up to Week 8, 12, or 16 depending on treatment duration)

  13. Palatability Questionnaire Question 5: How Easy or Difficult Was it for the Child to Swallow the Medicine?

    For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation. Question 5 "How Easy or Difficult Was it for the Child to Swallow the Medicine?" was answered as "very easy", "easy", "borderline", "difficult", or "very difficult."

    Measured: Final treatment visit (up to Week 8, 12, or 16, depending on treatment duration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2017
  2. Study start20 Mar 2017
  3. Primary completion21 May 2020
  4. Study completion12 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03067129
Sponsor's protocol ID
M16-123
Other IDs
2016-004102-34, 2016
Acronym
DORA
Status last verified
Apr 2023
First submitted
24 Feb 2017
Last updated
9 May 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Expanded access
Available

Publications

  • Thakre N, Beck D, Saeed AM, Eckert D, Chen MJ, Liu W, Lon HK, Mostafa NM, Mensing S. Population Pharmacokinetic Analysis of Glecaprevir and Pibrentasvir in Pediatric Patients >/= 3 to < 18 Years of Age with Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection. Clin Pharmacokinet. 2026 Jul;65(7):1061-1072. doi: 10.1007/s40262-026-01637-1. Epub 2026 May 26.

    PubMed 42189498

  • Jonas MM, Rhee S, Kelly DA, Del Valle-Segarra A, Feiterna-Sperling C, Gilmour S, Gonzalez-Peralta RP, Hierro L, Leung DH, Ling SC, Lobzin Y, Lobritto S, Mizuochi T, Narkewicz MR, Sabharwal V, Wen J, Kei Lon H, Marcinak J, Topp A, Tripathi R, Sokal E. Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Children With Chronic HCV: Part 2 of the DORA Study. Hepatology. 2021 Jul;74(1):19-27. doi: 10.1002/hep.31841.

    PubMed 33811356

  • Jonas MM, Squires RH, Rhee SM, Lin CW, Bessho K, Feiterna-Sperling C, Hierro L, Kelly D, Ling SC, Strokova T, Del Valle-Segarra A, Lovell S, Liu W, Ng TI, Porcalla A, Gonzalez YS, Burroughs M, Sokal E. Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Virus: Part 1 of the DORA Study. Hepatology. 2020 Feb;71(2):456-462. doi: 10.1002/hep.30840. Epub 2019 Aug 13.

    PubMed 31254392

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Glecaprevir/Pibrentasvir Adult Formulation and Glecaprevir + Pibrentasvir Pediatric Formulation in people with Hepatitis C Virus (HCV), run by AbbVie at 38 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Japan, Spain, Canada, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Steady-state Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of Glecaprevir (time frame: Week 2 from predose to 24 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03067129, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.

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