Proof-of-concept to Evaluate the Efficacy and Safety of Prednisone in Idiosyncratic Hepatotoxicity

NCT06251232 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: DILICORT
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial´s aim is to assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased total bilirubin (TBL): reduction of the peak of TBL at least 50% at 14 days or reduction in the time to normalisation of TBL value.

Conditions

Hepatotoxicity; Idiosyncratic Drug Effect; Prednisone

Keywords

Prednisone; Idiosyncrasic hepatotoxicity

Outcome Measures

Primary Outcomes (1)

• Total bilirubin

  To assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased total bilirubin (TBL): reduction of the peak of TBL at least 50% at 14 days or reduction in the time to normalisation of TBL value.

  Through study completation, an average 2 years

Secondary Outcomes (3)

• Peak alanine aminotransferase level

  2 years

• Aspartate aminotransferase level

  2 years

• International normalized ratio values

  Through study completation, an average 2 years

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

Oral prednisone

Drug: Prednisone

Placebo treatment

PLACEBO COMPARATOR

Placebo

Drug: Prednisone

Interventions

Prednisone DRUG

Placebo

Also known as: Comparator

Active treatment; Placebo treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male patients, aged ≥ 18 years.
• Patients who have been diagnosed with DILI by the expert committee.
• Patients with moderate to severe DILI (elevations of ALT or AST ≥ 5 times the Upper Limit of Normal (ULN) and serum TBL ≥ 2.5 mg/dL).
• Patients who do not show a 15% reduction in ALT values or TBL continues to increase 5-10 days after liver damage recognition despite the withdrawal of the culprit drug.

You may not qualify if:

• No clear DILI diagnosis after an expert committee DILI assessment.
• DILI due to immune-checkpoint inhibitors.
• Presence of active infection as evidenced by positive urine or blood culture.
• Acute liver failure (international normalized ratio (INR) \> 1.5 and hepatic encephalopathy).
• Model for End-Stage Liver Disease (MELD) ≥ 30.
• Known hypersensitivity to prednisone or placebo components.
• Pregnant or nursing mothers.
• Co-existing infection with hepatitis C, hepatitis B, or human immunodeficiency virus (HIV).
• Patients already receiving systemic steroids or other immunosuppressants.
• Inability to provide informed consent.
• Presence of clinically significant comorbid illnesses (by clinician's criteria) that might impede the completion of the study.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

MeSH Terms

Interventions

Prednisone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Raúl Andrade, PhD

  SAS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mª Isabel Lucena, PhD

CONTACT

34952131572; lucena@uma.es

Gloria Luque

CONTACT

34951291977; gloria.luque@ibima.eu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Prednisone medication and its placebo will be identical in appearance and in organoleptic properties.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled with placebo

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: February 9, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 5, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After 3 years
• Access Criteria: Open access