Proof-of-concept to Evaluate the Efficacy and Safety of P... | NCT06251232

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

NCT06251232

Sponsor

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

Status

Not yet recruiting

Last Update Posted

Apr 5, 2024Actual

Enrollment

60Estimated

Phase

Phase 2

Conditions

Hepatotoxicity
Idiosyncratic Drug Effect
Prednisone

Interventions

Prednisone

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2024Estimated

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Dec 12, 2023

First Submission Date that Met QC Criteria

Feb 1, 2024

First Posted Date

Feb 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2024

Last Update Posted Date

Apr 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

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, and to assess if oral prednisone (compared to placebo) is safe and well tolerated in patients with acute moderate to severe DILI.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active treatment	Active Comparator	Oral prednisone	Drug: Prednisone
Placebo treatment	Placebo Comparator	Placebo	Drug: Prednisone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prednisone	Drug	Placebo	Active treatment Placebo treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Peak alanine aminotransferase level	Comparison prednisone/placebo when reducing peak alanine aminotransferase (ALT), aspartate aminotransferase (AST) and international normalized ratio (INR) values by at least 50% at day 7 or reducing the time to normalisation.	2 years
Aspartate aminotransferase level

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Mª Isabel Lucena, PhD	Contact	34952131572		lucena@uma.es
Gloria Luque	Contact	34951291977		gloria.luque@ibima.eu

Name	Affiliation	Role
Raúl Andrade, PhD	SAS	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

National and international webs, manuscript

Types

Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

After 3 years

Access Criteria

Open access

URL

Not provided

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473