Hepatitis C, ChronicNCT01705717

A Retrospective Study of Real World Treatment Outcomes of Patients With Chronic Hepatitis C

An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 1 site in Thailand.

Completed

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

Trial summary

This retrospective, observational study will assess the real world treatment out comes in the management of patients with chronic hepatitis C. No prospective ass essment or procedure with patients during this study will be conducted. Data wil l be collected from patient medical records of the year 2000-2011. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic
How many people: 49 participants
Where: 1 siteThailand
Study dates: 1 Jun 2011to 1 May 2012
Phase: Observational
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Retrospective survey of medical records of patients with chronic hepatitis C

Who may be able to join

Patients newly diagnosed with chronic hepatitis C during the year 2000 to 2010
Availability of data for at least 6 months following the diagnosis date

Who cannot join

Patients who participated in an investigational clinical trial
Co-infection with hepatitis A, hepatitis B, hepatitis D, and/or human immunodeficiency virus (HIV)
Patients with known severe medical conditions that are contraindicated to HCV treatment

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Faculty of Medicine Vajira Hospital; Division of Gastroenterology and Hepatology
Bangkok, 10300

Other trials in Thailand

About this study

Official title: Treatment Outcomes in the Management of Patients With Chronic Hepatitis C: A Case Study of Faculty of Medicine Vajira Hospital, University of Bangkok Metropolis

Conditions: Hepatitis C, Chronic
Medical subject headings: Hepatitis C, Chronic

What participants receive

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

Study groups in NCT01705717
Study group	Role	What they receive
cohort		Not described

What is being measured

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

Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy
SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.
Measured: 6 months

Secondary outcomes (5)

Percentage of Participants Who Were HCV Seronegative at the End of Treatment
End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment.
Measured: End of Study, up to 36 months after diagnosis.
Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion
HCV relapse was determined by PCR RNA diagnostic testing. Virological relapse was defined as subsequent reappearance of serum HCV RNA after completion of therapy in participants who achieved end of treatment virological response (undetectable HCV RNA). Biochemical relapse was defined as subsequent rise in serum alanine aminotransferase (ALT) level after end of treatment with normal ALT.
Measured: End of Study, up to 36 months after diagnosis.
Percentage of Participants Who Progressed From CHC to Cirrhosis
Measured: Diagnosis and End of Study, up to 36 months after diagnosis.
Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)
Measured: Diagnosis and End of Study, up to 36 months after diagnosis.
Percentage of Participants Who Died
Any cause of death (including non-liver disease related) was reported.
Measured: Diagnosis and End of Study, up to 36 months after diagnosis

Timeline

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

1 Jun 20111 May 2012

First posted12 Oct 2012 (estimated)
Study start1 Jun 2011
Primary completion1 May 2012
Study completion1 May 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01705717
Sponsor's protocol ID: ML25436
Status last verified: Mar 2017
First submitted: 10 Oct 2012
Last updated: 10 Apr 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment Outcomes in the Management of Patients With Chronic Hepatitis C: A Case Study of Faculty of Medicine Vajira Hospital, University of Bangkok Metropolis
ClinicalTrials.gov ID: NCT01705717
Acronym / sponsor ID: ML25436
Conditions: Hepatitis C, Chronic
Study type: Observational
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 1 Jun 2011 (actual)
Primary completion: 1 May 2012 (actual)
Study completion: 1 May 2012 (actual)
First posted: 12 Oct 2012 (estimated)
Results: Posted 12 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
cohort	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Retrospective survey of medical records of patients with chronic hepatitis C

Key inclusion criteria (2 listed)

Patients newly diagnosed with chronic hepatitis C during the year 2000 to 2010
Availability of data for at least 6 months following the diagnosis date

Key exclusion criteria (3 listed)

Patients who participated in an investigational clinical trial
Co-infection with hepatitis A, hepatitis B, hepatitis D, and/or human immunodeficiency virus (HIV)
Patients with known severe medical conditions that are contraindicated to HCV treatment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy
Time frame: 6 months
SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.

5 secondary outcomes

Percentage of Participants Who Were HCV Seronegative at the End of Treatment
Time frame: End of Study, up to 36 months after diagnosis.
Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion
Time frame: End of Study, up to 36 months after diagnosis.
Percentage of Participants Who Progressed From CHC to Cirrhosis
Time frame: Diagnosis and End of Study, up to 36 months after diagnosis.
Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)
Time frame: Diagnosis and End of Study, up to 36 months after diagnosis.
Percentage of Participants Who Died
Time frame: Diagnosis and End of Study, up to 36 months after diagnosis

Results and safety

Results posted to the registry on 12 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-Cirrhotic Chronic Hepatitis C (CHC) Observation Only	37	35
Hepatitis C Virus (HCV) - Related Cirrhosis Observation Only	12	7

Primary outcome: Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy

Time frame: 6 months. Number. Unit: percentage of participants

Measure	Non-Cirrhotic CHC Observation Only n = 37	HCV - Related Cirrhosis Observation Only n = 12
Value	59.5	58.3

Population analysed: All enrolled participants.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were recorded from the begininng of treatment through the end of the study, approximately 36 months. This was a retrospective analysis study; safety reporting was generated spontaneously by physician discretion.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 47 (0%)	4 of 47 (8.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis C, Chronic

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 1 site in Thailand.

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 3 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 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2015). 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?

Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy (time frame: 6 months). 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 NCT01705717.

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 10 Apr 2017.