Liver CirrhosisPhase 2NCT05542615
Prolonged Release Pirfenidone for Advanced Residual Liver Fibrosis (MINERVA).
A Phase 2 study testing Prolonged-Release Pirfenidone in people with Liver Cirrhosis and Hepatitis C, Chronic, run by University of Guadalajara at 2 sites in Mexico.
Trial summary
Prolonged-Release Pirfenidone (PR-PFD) is an anti-fibrogenic and anti-inflammatory molecule used for the treatment of idiopathic pulmonary fibrosis (approved by FDA) and liver fibrosis (approved in Mexico by COFEPRIS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Hepatitis C, Chronic, Epigenetic Disorder
- What is being tested?
- Prolonged-Release Pirfenidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesMexico
- Study dates
- 1 Aug 2019to 1 Jan 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a history of Chronic Viral Hepatitis C, of all genotypes, demonstrated with previous studies (positive viral load).
- History of treatment with direct acting antivirals (AAD).
- Demonstration of negative viral load at least 6 months after completing treatment with AAD, considered as sustained viral response (SVR).
- Fibrotest and / or Liver Elastography test with advanced liver fibrosis scores (F3-F4).
- Verification of advanced liver fibrosis in a liver biopsy.
- Patients with Child Pugh functional class A or B and in stable clinical conditions (without active variceal hemorrhage, ascites or refractory encephalopathy) with consumption of drugs at stable doses in at least 30 days.
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- Laboratory tests that confirm her condition and functional class, with results that, in the opinion of the main researcher, do not put the patient at risk:
- Complete blood count, with hemoglobin values ≥ 10 g / dL, leukocytes ≥ 3,000 mL, platelets ≥ 50,000 mL
- Creatinine <1.8 mg / dL
Who cannot join
- Child Pugh functional class C (≥ 10 points)
- Pregnancy and lactation.
- History of known allergy or hypersensitivity to PFD.
- Having participated in another clinical study in the 60 days prior to the start of this one.
- Hospitalization within 30 days prior to the start of administration of the medication.
- Co-existing liver pathology: alcohol cirrhosis, hemochromatosis, Wilson's disease, α-1-antitrypsin deficiency, amyloidosis, autoimmune hepatitis, and Primary Biliary Cholangitis).
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- Concomitant systemic infection including viral hepatitis B, HIV, as well as respiratory infections, urinary, digestive, cellulite, etc.
- Serious concomitant conditions such as Heart Failure, Respiratory Failure and Chronic Kidney Failure.
- Malignant neoplasms including hepatocellular carcinoma. Patients with basal cell carcinoma or those with malignancies with more than 5 years of inactivity may be considered for the study.
- Decompensated diabetes mellitus (defined as that with fasting blood glucose values greater than 175 mg / dL and / or glycated hemoglobin greater than 8%).
- Uncontrolled hypertension despite medications (defined as systolic values ≥ 150 and diastolic values ≥ 100 mmHg).
- Patients with active alcohol intake in the last 6 months.
- Use of drugs known as concomitant hepatoprotectors (ursodexosicolic acid, s-adenosyl-methionine, silymarin, among others).
- Patients with treatment of CYP1A2 inhibitor drugs or other CYP isoenzymes such as: fluvoxamine, amiodarone, fluconazole, chloramphenicol, fluoxentine, paroxentine, ciprofloxacin, rifampin or propafenone, or other medicinal products that, in the opinion of the main investigator, may interfere with the study.
- Any other clinical condition that in the opinion of the main investigator could compromise the safety and well-being of the patient or jeopardize the conduct of the study.
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites, 1 recruiting
- Active, not recruiting
Institute for Molecular Biology in Medicine and Gene Therapy, CUCS, UdeG
Guadalajara, Jalisco, 44340
- Recruiting
Hospital Central Militar
Mexico City, 11200
Eira Cerda-Reyes, MD, +52 55 2122 1100 ext. 1510 - 1511, arieirace@yahoo.com.mx
About this study
Official title: Evaluation of Prolonged-release Pirfenidone in Patients With Viral C Hepatitis, With Sustained Viral Response and Advanced Residual Liver Fibrosis. Potential Role of Epigenetics to Understand Therapeutic Changes (MINERVA).
Prolonged-Release Pirfenidone (PR-PFD) is an anti-fibrogenic and anti-inflammatory molecule used for the treatment of idiopathic pulmonary fibrosis (approved by FDA) and liver fibrosis (approved in Mexico by COFEPRIS). PFD effects are mediated in part through inhibition of TGFβ, TNFα, IL-1 and IL-6, along with NFκB activation down-regulation causing reduced TNFα and IFNγ levels.
The aim of this protocol is to know if the epigenetic factors induced by PR-PFD have a regulatory role to understand the progression variants in liver fibrosis in a group of patients with viral hepatitis C, with a history of sustained viral response and advanced residual liver fibrosis. To assess the safety and efficacy of two daily doses of pirfenidone (KitosCell® LP), in patients with compensated liver cirrhosis.
Read the detailed description
Design: Observational clinical study, in an open population, of 12 months duration. Sixty patients with chronic Viral C hepatitis, who have been treated with direct-acting antivirals, with a sustained viral response and who still have advanced fibrosis (F3-F4).
Aim: to know if the epigenetic factors induced by PR-PFD have a regulatory role to understand the progression variants in liver fibrosis in a group of patients with viral hepatitis C, with a history of sustained viral response and advanced residual liver fibrosis. To assess the safety and efficacy of two daily doses of pirfenidone (KitosCell® LP), in patients with compensated liver cirrhosis.
Dosage: 1200 mg / day of Pirfenidone (KitosCell® LP) Variables to Analyze: Reduction of fibrosis and evaluation of epigenetic changes in the expression of various genes: PPARγ, PPARδ, PPARα, TGFβ1, Col1A1 and PDGFα. Additionally, changes in the expression levels of miR-122, miR192, miR-200a / b, miR-34a, miR-16, miR-21 and miR-181b will be evaluated, as well as changes in the transcriptome in ccfRNA.
Ethical considerations: The study will be conducted in accordance with the Declaration of Helsinki and the E6 Good Clinical Practice Standards International Conference on Harmonization (ICH).
Statistical Data Analysis: Descriptive statistics will be used and according to analytical statistical requirements that include parametric or non-parametric tests. The value of p <0.05 will be considered as significant.
- Conditions
- Liver Cirrhosis, Hepatitis C, Chronic, Epigenetic Disorder
- Being tested
- Prolonged-Release Pirfenidone
- Medical subject headings
- Liver Cirrhosis, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged-Release PirfenidoneDrug
1200 mg / day of Pirfenidone (KitosCell® LP)
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Sixty patients with chronic Viral C hepatitis, who have been treated with direct-acting antivirals, with a sustained viral response and who still have advanced fibrosis (F3-F4). Receives: Drug: Prolonged-Release Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver biopsy
Reduction of one unit in the METAVIR histological scale (F0-F4)
Measured: 12 months
Elastography
≥30% reduction in the final Pascal score, compared to baseline.
Measured: 12 months
Secondary outcomes (4)
Changes in the degree of methylation
of the following genes PPARγ, PPARζ, PPARα, TGFβ1, Col1A1 and PDGFα in ccfDNA in DNA obtained by liver biopsy.
Measured: 12 months
Changes in expression levels of miRNA's
Changes in expression levels of miR-122, miR192, miR-200a / b, miR-221/222, miR-34a, miR-16, miR-21, and miR-181b.
Measured: 12 months
Transcriptome measurement in ccfRNA
Changes in transcriptome measurement in ccfRNA
Measured: 12 months
Albumin and liver enzyme values
Albumin and liver enzyme values
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Aug 2019
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
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 Liver CirrhosisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a real-life, open-label, proof of concept trial to assess the safety and efficacy of two daily doses of pirfenidone (KitosCell® LP), in patients with compensated liver cirrhosis.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Central Militar
- Responsible party
- Principal investigator, Juan Armendáriz-Borunda, PhD, FAASLD, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542615
- Sponsor's protocol ID
- MINERVA
- Status last verified
- Jul 2023
- First submitted
- 13 Sep 2022
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cerda-Reyes E, de la Rosa-Bibiano R, Sandoval-Rodriguez A, Rosas-Campos R, Torre A, Cornejo-Hernandez S, Escutia-Gutierrez R, Vazquez-Esqueda A, Gutierrez-Cuevas J, Gutierrez-Atemis A, Amezquita-Perez S, Poo JL, Garrido-Sanchez GA, Bastida-Alquicira J, Saldana-Rivera E, Lozano-Trenado LM, Ramon-Aguilar J, Madrigal JA, Armendariz-Borunda J. HCV patients with residual fibrosis after DAA treatment re-establish their epigenetic signature after prolonged-release pirfenidone: MINERVA study. Clin Epigenetics. 2025 Oct 3;17(1):157. doi: 10.1186/s13148-025-01969-y.
PubMed 41044745
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prolonged-release Pirfenidone in Patients With Viral C Hepatitis, With Sustained Viral Response and Advanced Residual Liver Fibrosis. Potential Role of Epigenetics to Understand Therapeutic Changes (MINERVA).
- ClinicalTrials.gov ID
- NCT05542615
- Acronym / sponsor ID
- MINERVA
- Conditions
- Liver Cirrhosis, Hepatitis C, Chronic, Epigenetic Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Collaborators
- Hospital Central Militar
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 15 Sep 2022 (actual)
- 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.
Prolonged-Release Pirfenidone (PR-PFD) is an anti-fibrogenic and anti-inflammatory molecule used for the treatment of idiopathic pulmonary fibrosis (approved by FDA) and liver fibrosis (approved in Mexico by COFEPRIS). PFD effects are mediated in part through inhibition of TGFβ, TNFα, IL-1 and IL-6, along with NFκB activation down-regulation causing reduced TNFα and IFNγ levels.
The aim of this protocol is to know if the epigenetic factors induced by PR-PFD have a regulatory role to understand the progression variants in liver fibrosis in a group of patients with viral hepatitis C, with a history of sustained viral response and advanced residual liver fibrosis. To assess the safety and efficacy of two daily doses of pirfenidone (KitosCell® LP), in patients with compensated liver cirrhosis.
Detailed description
Design: Observational clinical study, in an open population, of 12 months duration. Sixty patients with chronic Viral C hepatitis, who have been treated with direct-acting antivirals, with a sustained viral response and who still have advanced fibrosis (F3-F4).
Aim: to know if the epigenetic factors induced by PR-PFD have a regulatory role to understand the progression variants in liver fibrosis in a group of patients with viral hepatitis C, with a history of sustained viral response and advanced residual liver fibrosis. To assess the safety and efficacy of two daily doses of pirfenidone (KitosCell® LP), in patients with compensated liver cirrhosis.
Dosage: 1200 mg / day of Pirfenidone (KitosCell® LP) Variables to Analyze: Reduction of fibrosis and evaluation of epigenetic changes in the expression of various genes: PPARγ, PPARδ, PPARα, TGFβ1, Col1A1 and PDGFα. Additionally, changes in the expression levels of miR-122, miR192, miR-200a / b, miR-34a, miR-16, miR-21 and miR-181b will be evaluated, as well as changes in the transcriptome in ccfRNA.
Ethical considerations: The study will be conducted in accordance with the Declaration of Helsinki and the E6 Good Clinical Practice Standards International Conference on Harmonization (ICH).
Statistical Data Analysis: Descriptive statistics will be used and according to analytical statistical requirements that include parametric or non-parametric tests. The value of p <0.05 will be considered as significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a real-life, open-label, proof of concept trial to assess the safety and efficacy of two daily doses of pirfenidone (KitosCell® LP), in patients with compensated liver cirrhosis.
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Drug: Prolonged-Release PirfenidoneSixty patients with chronic Viral C hepatitis, who have been treated with direct-acting antivirals, with a sustained viral response and who still have advanced fibrosis (F3-F4). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with a history of Chronic Viral Hepatitis C, of all genotypes, demonstrated with previous studies (positive viral load).
- History of treatment with direct acting antivirals (AAD).
- Demonstration of negative viral load at least 6 months after completing treatment with AAD, considered as sustained viral response (SVR).
- Fibrotest and / or Liver Elastography test with advanced liver fibrosis scores (F3-F4).
- Verification of advanced liver fibrosis in a liver biopsy.
Key exclusion criteria (15 listed)
- Child Pugh functional class C (≥ 10 points)
- Pregnancy and lactation.
- History of known allergy or hypersensitivity to PFD.
- Having participated in another clinical study in the 60 days prior to the start of this one.
- Hospitalization within 30 days prior to the start of administration of the medication.
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 |
|---|---|---|
| Prolonged-Release Pirfenidone1200 mg / day of Pirfenidone (KitosCell® LP) | Drug | Patient |
Primary outcome
Liver biopsy
Time frame: 12 months
Reduction of one unit in the METAVIR histological scale (F0-F4)
Elastography
Time frame: 12 months
≥30% reduction in the final Pascal score, compared to baseline.
4 secondary outcomes
Changes in the degree of methylation
Time frame: 12 months
Changes in expression levels of miRNA's
Time frame: 12 months
Transcriptome measurement in ccfRNA
Time frame: 12 months
Albumin and liver enzyme values
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Derived from this study: PubMed 41044745Cerda-Reyes E, de la Rosa-Bibiano R, Sandoval-Rodriguez A, Rosas-Campos R, Torre A, Cornejo-Hernandez S, Escutia-Gutierrez R, Vazquez-Esqueda A, Gutierrez-Cuevas J, Gutierrez-Atemis A, Amezquita-Perez S, Poo JL, Garrido-Sanchez GA, Bastida-Alquicira J, Saldana-Rivera E, Lozano-Trenado LM, Ramon-Aguilar J, Madrigal JA, Armendariz-Borunda J. HCV patients with residual fibrosis after DAA treatment re-establish their epigenetic signature after prolonged-release pirfenidone: MINERVA study. Clin Epigenetics. 2025 Oct 3;17(1):157. doi: 10.1186/s13148-025-01969-y.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prolonged-Release Pirfenidone in people with Liver Cirrhosis and Hepatitis C, Chronic, run by University of Guadalajara at 2 sites in Mexico.
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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Armendariz-Borunda, PhD, FAASLD (+52 1058 5200 ext. 34882, armdbo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver biopsy (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT05542615, 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 6 Jul 2023.