Hepatitis C, ChronicNCT01850745

Multidisciplinary Support Program in Chronic Hepatitis C

An observational study of Hepatitis C, Chronic, run by Parc de Salut Mar at 1 site in Spain.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: Multidisciplinary support program
How many people: 447 participants
Where: 1 siteSpain
Study dates: Jan 2003to Jan 2010
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: Chronic hepatitis C virus infection (CHC)

Who may be able to join

Patients with chronic hepatitis C eligible to receive antiviral treatment.

Who cannot join

Patients who had undergone previous antiviral treatment, those with human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection, and individuals included in other treatment protocols.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital del Mar
Barcelona, 08003

Other trials in Spain

About this study

Official title: Evaluation of a multidìsciplinary Support Program in the Adherence and Efficacy of Peginterferon Alfa-2a and Ribavirin Therapy in Chronic Hepatitis C.

Adherence to antiviral treatment in chronic hepatitis C (CHC) is an important factor to achieve sustained virological response (SVR). The aim of our study is to evaluate the efficacy of a multidisciplinary support program (MSP) in adherence to and efficacy of pegylated interferon alfa-2a and ribavirin compared to the conventional approach. We assessed 447 patients with CHC receiving antiviral treatment distributed into 3 groups: control group (recruited 2002-2004, n= 147), MSP-pilot group (recruited 2005-2006, n=131), and MSP-validation group (recruited 2007-2009, n=169).

Read the detailed description

Adherence to antiviral treatment in chronic hepatitis C (CHC) is an important factor to achieve sustained virological response (SVR). The aim of our study is to evaluate the efficacy of a multidisciplinary support program (MSP) in adherence to and efficacy of pegylated interferon alfa-2a and ribavirin compared to the conventional approach. We assessed 447 patients with CHC receiving antiviral treatment distributed into 3 groups: control group (follow-up 2002-2004, n= 147), MSP-pilot group (follow-up 2005-2006, n=131), and MSP-validation group (follow-up 2007-2009, n=169).A cost-effectiveness analysis was performed using a Markov model.

Conditions: Hepatitis C, Chronic
Being tested: Multidisciplinary support program
Keywords: Chronic hepatitis C virus infection (CHC)
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.

Multidisciplinary support programOther
Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.

Study groups in NCT01850745
Study group	Role	What they receive
Control		Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program
Validation cohort		Prospective group. Usual treatment with peginterferon-2a and ribavirin. Multidisciplinary support program. Receives: Other: Multidisciplinary support program
Pilot cohort		Prospective intervention group. Usual pharmacological treatment with peginterferon-2a and ribavirin. Multidisciplinary support program. Receives: Other: Multidisciplinary support program

What is being measured

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

Adherence to Treatment
Adherent patients were defined as those receiving equal or more than 80% of total dose of pegylated interferon (180 microg/week) and ribavirin (1200 mg/d) during equal o more than 80% of duration treatment (48 weeks).
Non-adherent patients were defined as those receiving less than 80% of total dose of pegylated interferon (180 microg/week) and ribavirin (1200 mg/d) during less than 80% of duration treatment (48 weeks).
Measured: 48 months

Secondary outcomes (1)

Efficacy of Treatment Measured by Sustained Virological Response
The secondary efficacy end point was to evaluate the sustained virological response (SVR) of antiviral treatment.
SVR was defined as undetectable hepatitis C virus viral load (<15 IU/ml) 24 weeks after treatment completion.
Non-SVR was defined as detectable hepatitis C virus viral load (>15 IU/ml) 24 weeks after treatment completion.
Measured: baseline and 72 weeks

Timeline

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

Jan 2003Jan 2010

First posted9 May 2013 (estimated)
Study startJan 2003
Primary completionJan 2009
Study completionJan 2010

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.
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: Other
Enrolment: 447 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01850745
Sponsor's protocol ID: HMAR-MSP-CHC
Status last verified: May 2013
First submitted: 7 May 2013
Last updated: 20 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of a multidìsciplinary Support Program in the Adherence and Efficacy of Peginterferon Alfa-2a and Ribavirin Therapy in Chronic Hepatitis C.
ClinicalTrials.gov ID: NCT01850745
Acronym / sponsor ID: HMAR-MSP-CHC
Conditions: Hepatitis C, Chronic
Keywords: Chronic hepatitis C virus infection (CHC)
Study type: Observational
Recruitment status: Completed
Enrolment: 447 participants (actual)
Lead sponsor: Parc de Salut MarUniversity, hospital or other
Study start: Jan 2003
Primary completion: Jan 2009 (actual)
Study completion: Jan 2010 (actual)
First posted: 9 May 2013 (estimated)
Results: Posted 13 Jul 2018

Clinical summary

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

Detailed description

Adherence to antiviral treatment in chronic hepatitis C (CHC) is an important factor to achieve sustained virological response (SVR). The aim of our study is to evaluate the efficacy of a multidisciplinary support program (MSP) in adherence to and efficacy of pegylated interferon alfa-2a and ribavirin compared to the conventional approach. We assessed 447 patients with CHC receiving antiviral treatment distributed into 3 groups: control group (follow-up 2002-2004, n= 147), MSP-pilot group (follow-up 2005-2006, n=131), and MSP-validation group (follow-up 2007-2009, n=169).A cost-effectiveness analysis was performed using a Markov model.

Study design

Observational model: Cohort
Time perspective: Other
Number of arms: 3

Arm	Type	Receives
Control	–	–Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program
Validation cohort	–	Other: Multidisciplinary support programProspective group. Usual treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.
Pilot cohort	–	Other: Multidisciplinary support programProspective intervention group. Usual pharmacological treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Chronic hepatitis C virus infection (CHC)

Key inclusion criteria (1 listed)

Patients with chronic hepatitis C eligible to receive antiviral treatment.

Key exclusion criteria (1 listed)

Patients who had undergone previous antiviral treatment, those with human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection, and individuals included in other treatment protocols.

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

Interventions

Intervention	Type	Arms
Multidisciplinary support programMultidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.	Other	Pilot cohort, Validation cohort

Primary outcome

Adherence to Treatment
Time frame: 48 months
Adherent patients were defined as those receiving equal or more than 80% of total dose of pegylated interferon (180 microg/week) and ribavirin (1200 mg/d) during equal o more than 80% of duration treatment (48 weeks). Non-adherent patients were defined as those receiving less than 80% of total dose of pegylated interferon (180 microg/week) and ribavirin (1200 mg/d) during less than 80% of duration treatment (48 weeks).

1 secondary outcome

Efficacy of Treatment Measured by Sustained Virological Response
Time frame: baseline and 72 weeks

Results and safety

Results posted to the registry on 13 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	147	147
Validation Cohort	169	169
Pilot Cohort	131	131

Primary outcome: Adherence to Treatment

Time frame: 48 months. Number. Unit: participants

Measure	Control n = 147	Validation Cohort n = 169	Pilot Cohort n = 131
Value	116	155	124

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	2 of 147 (1.4%)	52 of 147 (35.4%)	0 of 147
Validation Cohort	2 of 169 (1.2%)	14 of 169 (8.3%)	0 of 169
Pilot Cohort	2 of 131 (1.5%)	4 of 131 (3.1%)	0 of 131

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
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.

Ricard Sola, MD principal investigator

Hsopital del Mar, Parc de Salut MAR

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 Parc de Salut Mar at 1 site in Spain.

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 1 inclusion and 1 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 20 Sep 2021. 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 Spain. 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 13 Jul 2018). 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?

Adherence to Treatment (time frame: 48 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 NCT01850745.

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 20 Sep 2021.