NCT02638233

Brief Summary

Patients with chronic hepatitis C that are under opiate substitution therapy are likely to have psychiatric comorbidities such as depression; hence an Interferon based therapy is contraindicated. Additionally many of these patients have a borderline compliance, which makes it impossible to treat them at specialized hepatological centers. An ideal opportunity to treat this patients is treatment with DAAs (Direct Acting Antiviral) which can be administered daily together with the opiate substitution therapy at a low threshold facility.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

1 year

First QC Date

October 5, 2015

Last Update Submit

December 18, 2015

Conditions

Chronic Hepatitis C

Keywords

CHCIVDA (intravenous drug abuse)Hepatitis CSofosbuvirLedipasvirOpiate Substitution Therapy

Outcome Measures

Primary Outcomes (1)

  • Percentage of pills taken during the treatment phase will be calculated as a parameter for adherence to therapy for each individual subject.

    Study drugs will administered daily together with the opiate substitution therapy under the supervision of qualified site personnel and recorded on a worksheet for each subject. At the end of the treatment phase, the total number of DAA pills taken will be assessed as percentage for each subject and for the whole study population.

    8 Weeks

Secondary Outcomes (3)

  • Sustained Virologic Response (SVR) 12 Weeks after End of Therapy (SVR 12)

    12 Weeks after end of Therapy

  • Sustained Virologic Response (SVR) 24 Weeks after End of Therapy (SVR 24)

    24 Weeks after end of Therapy

  • Safety and tolerability (total number of observed adverse events)

    20 weeks

Study Arms (1)

Sofosbuvir 400mg/Ledipasvir 90 mg

OTHER

Subjects will receive sofosbuvir 400mg q.d p.o and ledipasvir 90 mg q.d p.o (FDC) for 8 weeks

Drug: Sofosbuvir 400mg / Ledipasvir 90 mg (FDC)

Interventions

Sofosbuvir 400mg / Ledipasvir 90 mg (FDC)DRUG
Also known as: Harvoni
Sofosbuvir 400mg/Ledipasvir 90 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic genotype 1 HCV infection
  • Fibrosis F0-F3 (i.e. non-cirrhotic confirmed by Fibroscan \<12.5kPa)
  • Stable opiate substitution therapy
  • Regular visits at the low threshold facility during the last month

You may not qualify if:

  • Lack or unwillingness of safe contraception, pregnancy
  • Liver cirrhosis (Fibroscan ≥12.5kPa)
  • Coinfection with HBV (Hepatitis B Virus) or HIV (coinfection with HIV is excluded only because there are very few coinfected patients under care at the "Ambulatorium Suchthilfe Wien" and hence this subpopulation would be very small)
  • Severe comorbidities resulting in a life expectancy of less than five years
  • HCC (Hepatocellular carcinoma)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilhelminenspital

Vienna, Vienna, 1160, Austria

RECRUITING

Related Publications (1)

  • Schutz A, Moser S, Schwanke C, Schubert R, Luhn J, Gutic E, Lang T, Schleicher M, Haltmayer H, Gschwantler M. Directly observed therapy of chronic hepatitis C with ledipasvir/sofosbuvir in people who inject drugs at risk of nonadherence to direct-acting antivirals. J Viral Hepat. 2018 Jul;25(7):870-873. doi: 10.1111/jvh.12857. Epub 2018 Feb 6.

    PMID: 29316001DERIVED

MeSH Terms

Conditions

Hepatitis C, ChronicSubstance Abuse, IntravenousHepatitis C

Interventions

Sofosbuvirledipasvirledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Michael Gschwantler, Prof. MD

    Wilhelminenspital Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Gschwantler, Prof. MD

CONTACT

0043 1 49150 2401michael.gschwantler@wienkav.at

Johann Haltmayer, MD, HCM

CONTACT

0043 1 4000 53603hans.haltmayer@sd-wien.at

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr

Study Record Dates

First Submitted

October 5, 2015

First Posted

December 23, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 23, 2015

Record last verified: 2015-12

Locations

AU(1)