Intravenous NAC Use in ACLF Patients

NCT05089981 | Unknown DMC

• 1 other identifier: 2021-1245-13480
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective To evaluate the efficacy and safety of 72 hour NAC treatment regimen in the management of ACLF Secondary Objective To evaluate the six weeks mortality and length of hospital stay in ACLF patients treated with NAC Randomized, Double blind pilot study of IV N-Acetyl cysteine for the treatment of ACLF. Participants will be randomized into intervention and control arm using block randomization by computer generated random numbers. Efficacy will be assessed by clinical improvement in symptoms and signs of decompensated chronic liver disease (CLD). To assess safety degree of adverse reactions will be observed. Periodic assessments until 28 day will be done consisting of Physical exam, safety assessments, vital signs and lab tests. Dose of Drug: 72 hour regimen consisting of three doses of intravenous N-Acetyl cysteine will be used for a total dose of 300mg/kg. Number of Patients: 100 Accrual period: 15 months

Conditions

Acute on Chronic Liver Failure(ACLF)

Outcome Measures

Primary Outcomes (1)

• Efficacy & safety of NAC in the improvement of ACLF To evaluate the efficacy and safety of 72 hour NAC treatment regimen in the management of ACLF

  clinical and biochemical improvement will be noted as NAC efficacy and safety through AE \& SAE

  72 hrs

Secondary Outcomes (2)

• 6-weeks Survival

  6 weeks

• Length of hospital stay

  6 weeks

Study Arms (2)

NAC group

ACTIVE COMPARATOR

IV N acetyl cysteine 300mg will be administered in doses as described in protocol

Drug: N acetyl cysteine

NAC Placebo group

PLACEBO COMPARATOR

IV Placebo of N acetyl cysteine will be administered in doses as described in protocol (Placebo will be normal saline in a look alike preparation with same volume as active NAC arm)

Drug: Placebo of N acetyl cysteine

Interventions

N acetyl cysteine DRUG

Intravenous use of N acetyl cysteine in prescribed doses

NAC group

Placebo of N acetyl cysteine DRUG

Intravenous Placebo of N Acetyl cysteine in look alike form (Normal saline)

NAC Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years
• Establishment of ACLF grade 1-3 according to EASL- CLIFF criteria
• Willing to provide informed consent to participate in the study (by study subject or next of kin)

You may not qualify if:

• History of hypersensitivity to NAC
• Hepatocellular carcinoma
• pregnancy
• Advanced cardiovascular or pulmonary disease
• Advanced primary neurological disease (such as stroke)

Sponsors & Collaborators

• Aga Khan University: lead
• National Institute of Liver & GI Diseases, Pakistan: collaborator

Study Sites (1)

Aga Khan University,

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double Blind Placebo Controlled

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 22, 2021
• Study Start: November 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)