NCT03868163

Brief Summary

This study seeks to assess the effectiveness of Glecaprevir plus Pibrentasvir in participants with chronic hepatitis C in a real-life setting across clinical practice populations in the Russian Federation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2020

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

March 7, 2019

Last Update Submit

August 25, 2021

Conditions

Chronic Hepatitis C (CHC)

Keywords

Chronic Hepatitis CHepatitis CHepatitisglecaprevirpibrentasvirreal world settingObservational Study

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)

    SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification/detection (\<LLOQ/D) 12 weeks after the last dose of Glecaprevir plus Pibrentasvir (GLE/PIB).with a sensitive polymerase chain reaction \[PCR\] test with an LLoQ/D of \<50 IU/mL or as described in a validated assay.

    Up to approximately 28 weeks

Secondary Outcomes (10)

  • Percentage of Participants Achieving SVR12 by Mono HCV or co-infected HCV/HIV Status

    Up to approximately 28 weeks

  • Percentage of Participants Achieving SVR12 by CHC Genotype

    Up to approximately 28 weeks

  • Percentage of Participants Achieving SVR12 by Cirrhosis Status

    Up to approximately 28 weeks

  • Percentage of Participants Achieving SVR12 by Previous Treatment Experience

    Up to approximately 28 weeks

  • Percentage of Participants Achieving SVR12 by Patients Who Use Drugs

    Up to approximately 28 weeks

  • +5 more secondary outcomes

Study Arms (1)

Glecaprevir plus Pibrentasvir

Participants in this observational study will receive treatment with glecaprevir and pibrentasvir for up to 16 weeks for treatment of chronic hepatis C (CHC) genotypes 1, 2, 3, 4, 5, or 6. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice, international guidelines and/or label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with CHC in a real world clinical practice setting.

You may qualify if:

  • Treatment-naïve or - pegIFN (or IFN), and/or Ribavirin (RBV) and/or sofosbuvir (PRS) experienced with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines and in line with the current local label.
  • May be enrolled up to 4 weeks after treatment initiation.
  • Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

LLC Medical Company Hepatolog /ID# 212384

Samara, Samara Oblast, 443063, Russia

Location

Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 217035

Stavropol, Stavropol Kray, 355035, Russia

Location

A. F. Agafonov Republican Clin /ID# 212381

Kazan', Tatarstan, Respublika, 420140, Russia

Location

South Ural State Medical univ /ID# 212020

Chelyabinsk, 454052, Russia

Location

Clinical Inf. Dis Hospital 1 /ID# 217033

Novosibirsk, 630099, Russia

Location

SIH Orlovskiy region city hospital named after S.P. Botkin /ID# 212383

Oryol, 302038, Russia

Location

Perm Regional Center of Cepato /ID# 213992

Perm, 614000, Russia

Location

Saint-Petersburg AIDS Center /ID# 212380

Saint Petersburg, 190103, Russia

Location

Samara State Medical Universit /ID# 217029

Samara, 443099, Russia

Location

Related Links

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis CHepatitis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 8, 2019

Study Start

February 28, 2019

Primary Completion

September 4, 2020

Study Completion

September 4, 2020

Last Updated

August 30, 2021

Record last verified: 2021-08

Locations

RU(9)