FibrosisPhase 2NCT02161952

Pirfenidone, an Antifibrotic and Antiinflammatory Drug

A Phase 2 study testing Pirfenidone in people with Fibrosis and Hepatitis C Chronic, run by University of Guadalajara.

Completed

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

Trial summary

The aim of this study was to assess whether two-year treatment with Pirfenidone influence necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis C. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Fibrosis, Hepatitis C Chronic
What is being tested?: Pirfenidone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: No sites listed yet
Study dates: May 2005to Aug 2007
Phase: Phase 2
Are there results?: None posted in the registry

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients with established advanced liver disease caused by hepatitis C virus (HCV) chronic infection defined by a positive test for anti-HCV antibodies and detectable serum HCV RNA (Amplicor HCV 2.0 polymerase chain reaction (PCR) assay).
Sign an informed consent form to allow the collection of liver biopsies before and after treatment.
No antifibrotic, antiviral or immunosuppressive drugs for at least 6 months before starting pirfenidone therapy.
No alcohol intake for at least 6 months before nor during Pirfenidone (PFD) treatment.

Who cannot join

Patients with clinical contraindications to hepatic biopsy

About this study

Official title: Pirfenidone, an Antifibrotic and Antiinflammatory Drug for Treatment of Patients With Cirrhosis Due to Hepatitis C Virus. Phase II/III Study

The aim of this study was to assess whether two-year treatment with Pirfenidone influence necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis C.

Conditions: Fibrosis, Hepatitis C Chronic
Being tested: Pirfenidone, Matched equivalent placebo
Keywords: Fibrosis, necroinflammation, hepatitis C chronic
Medical subject headings: Fibrosis, Hepatitis C, Chronic

What participants receive

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

PirfenidoneDrug
Also called 5 methyl-1-phenil-2 (1H)-pyridone
Pirfenidone was supplied orally in 400 mg gel capsules three times daily (every 8 hours) for a full dosage of 1200 mg daily during 24 months.
Matched equivalent placeboDrug

Study groups in NCT02161952
Study group	Role	What they receive
Pirfenidone	Experimental	Pirfenidone 400 mg capsules, orally administered thrice daily to yield a daily dose of 1200 mg during two years. Receives: Drug: Pirfenidone
Matched equivalent placebo	Placebo comparator	Matched equivalent placebo Receives: Drug: Matched equivalent placebo

What is being measured

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

Fibrosis staging
Fibrosis was evaluated according to Ishak fibrosis staging scale.
Measured: 24 months

Secondary outcomes (1)

Grade of necroinflammation activity
Necroinflammatory activity was evaluated according to the Ishak modified histological activity index (HAI).
Measured: 24 months

Timeline

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

May 2005Aug 2007

First posted12 Jun 2014 (estimated)
Study startMay 2005
Primary completionAug 2006
Study completionAug 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for FibrosisStudies 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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02161952
Sponsor's protocol ID: IBMMTG.05
Other IDs: HCG, No. Registry 505/05
Status last verified: Jun 2014
First submitted: 10 Jun 2014
Last updated: 9 Jul 2014
Results posted: No
Data monitoring committee: Yes

Publications

Flores-Contreras L, Sandoval-Rodriguez AS, Mena-Enriquez MG, Lucano-Landeros S, Arellano-Olivera I, Alvarez-Alvarez A, Sanchez-Parada MG, Armendariz-Borunda J. Treatment with pirfenidone for two years decreases fibrosis, cytokine levels and enhances CB2 gene expression in patients with chronic hepatitis C. BMC Gastroenterol. 2014 Jul 27;14:131. doi: 10.1186/1471-230X-14-131.
PubMed 25064094

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?

Official record

Not yet recruitingPhase 2
Effectiveness of Oxitard Gel Versus Physiotherapeutic and Pharmacological Interventions in Alleviating Oral Submucous Fibrosis: A Phase-II Randomized Control Trial
Oral and Maxillofacial Conditions
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Graft vs Host Disease
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis

All Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pirfenidone, an Antifibrotic and Antiinflammatory Drug for Treatment of Patients With Cirrhosis Due to Hepatitis C Virus. Phase II/III Study
ClinicalTrials.gov ID: NCT02161952
Acronym / sponsor ID: IBMMTG.05
Conditions: Fibrosis, Hepatitis C Chronic
Keywords: Fibrosis, necroinflammation, hepatitis C chronic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: University of GuadalajaraUniversity, hospital or other
Collaborators: Cell Therapy And Technology, S.a. De C.v.
Study start: May 2005
Primary completion: Aug 2006 (actual)
Study completion: Aug 2007 (actual)
First posted: 12 Jun 2014 (estimated)
Results: Not posted in the source record

Clinical summary

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

The aim of this study was to assess whether two-year treatment with Pirfenidone influence necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis C.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Pirfenidone	Experimental	Drug: PirfenidonePirfenidone 400 mg capsules, orally administered thrice daily to yield a daily dose of 1200 mg during two years.
Matched equivalent placebo	Placebo comparator	Drug: Matched equivalent placeboMatched equivalent placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients with established advanced liver disease caused by hepatitis C virus (HCV) chronic infection defined by a positive test for anti-HCV antibodies and detectable serum HCV RNA (Amplicor HCV 2.0 polymerase chain reaction (PCR) assay).
Sign an informed consent form to allow the collection of liver biopsies before and after treatment.
No antifibrotic, antiviral or immunosuppressive drugs for at least 6 months before starting pirfenidone therapy.
No alcohol intake for at least 6 months before nor during Pirfenidone (PFD) treatment.

Key exclusion criteria (1 listed)

Patients with clinical contraindications to hepatic biopsy

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
PirfenidoneAlso: 5 methyl-1-phenil-2 (1H)-pyridonePirfenidone was supplied orally in 400 mg gel capsules three times daily (every 8 hours) for a full dosage of 1200 mg daily during 24 months.	Drug	Pirfenidone
Matched equivalent placebo	Drug	Matched equivalent placebo

Primary outcome

Fibrosis staging
Time frame: 24 months
Fibrosis was evaluated according to Ishak fibrosis staging scale.

1 secondary outcome

Grade of necroinflammation activity
Time frame: 24 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
Derived from this study: PubMed 25064094Flores-Contreras L, Sandoval-Rodriguez AS, Mena-Enriquez MG, Lucano-Landeros S, Arellano-Olivera I, Alvarez-Alvarez A, Sanchez-Parada MG, Armendariz-Borunda J. Treatment with pirfenidone for two years decreases fibrosis, cytokine levels and enhances CB2 gene expression in patients with chronic hepatitis C. BMC Gastroenterol. 2014 Jul 27;14:131. doi: 10.1186/1471-230X-14-131.

Related trials for Fibrosis

Not yet recruitingPhase 2
Effectiveness of Oxitard Gel Versus Physiotherapeutic and Pharmacological Interventions in Alleviating Oral Submucous Fibrosis: A Phase-II Randomized Control Trial
Oral and Maxillofacial Conditions
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Graft vs Host Disease
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis

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.

Juan Armendariz-Borunda, Ph. D. principal investigator

Head, Molecular Biology and Genomics Department

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pirfenidone in people with Fibrosis and Hepatitis C Chronic, run by University of Guadalajara.

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 4 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 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

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

What does this 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Fibrosis staging (time frame: 24 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 NCT02161952, which also lists 1 linked publication.

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 Jul 2014.