NCT05545670

Brief Summary

The study aims to compare the potential benefit of allopurinol in reducing the risk of developing cirrhosis-related complications, delaying the onset of hepatocellular carcinoma, and improving survival. Furthermore, the study aims to evaluate their impact on parents' related quality of life

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

September 15, 2022

Last Update Submit

May 7, 2023

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • morbidities

    occurrence or exacerbation of complication

    6 moths

Study Arms (2)

placebo

PLACEBO COMPARATOR

Group1: (Placebo, n=50) who will receive oral placebo tablet once daily FOR 6 MONTHS

Drug: Placebo

allopurinol

ACTIVE COMPARATOR

Group 2:(Allopurinol n=50) who will receive oral allopurinol 300 mg daily for 6 months

Drug: Allopurinol 300 MG

Interventions

PlaceboDRUG

not containing drugs

placebo
Allopurinol 300 MGDRUG

a competitive xanthine oxidase inhibitor, reduces oxidative stress and attenuates bacterial translocation

allopurinol

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ge 18 to 75 years old Both sex Adults with cirrhosis in a stable conditions

You may not qualify if:

  • Active SBP Renal insufficiency (serum creatinine \> 2.0 mg/dl) Active GIT hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Pharmacy

Tanta, 31679, Egypt

Location

Related Publications (1)

  • Glal KAM, El-Haggar SM, Abdel-Salam SM, Mostafa TM. Allopurinol Prevents Cirrhosis-Related Complications: A Quadruple Blind Placebo-Controlled Trial. Am J Med. 2024 Jan;137(1):55-64. doi: 10.1016/j.amjmed.2023.09.016. Epub 2023 Oct 12.

    PMID: 37832758DERIVED

MeSH Terms

Conditions

Fibrosis

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 19, 2022

Study Start

June 15, 2022

Primary Completion

February 15, 2023

Study Completion

March 1, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations

EG(1)