Direct Acting Anti-Viral's In Chronic HCV Patients

NCT04664894 | Completed

• 1 other identifier: GTZ-NLRF-001
• Study Type: observational
• Target: 511
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to determine the safety of DAA's among chronic HCV patients. The outcomes of the study are; To determine the frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon To calculate the percentage of patients with severity of medical event as per Karch and Lasagna classification To determine the percentage of patient having serious adverse event as per ICH Classification

Conditions

Safety Issues

Keywords

adverse events; chronic hepatitis; direct acting antivirals

Outcome Measures

Primary Outcomes (1)

• Frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon

  Frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon

  12 months

Secondary Outcomes (1)

• Percentage of patients reported severity of medical event as per Karch and Lasagna classification

  12 months

Other Outcomes (1)

• Percentage of patient having serious adverse event as per ICH Classification

  12 months

Interventions

Sofosbuvir DRUG

the occurrence of AEs (AE) and their severity among chronic HCV patients has assessed in patinets receiving different combinations of DAAs in Pakistani Population

Also known as: Daclatasvir, Ribavirin, Velpatasvir

Eligibility Criteria

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

Study Population

Patients with chronic hepatitis C on DAAs therapy were included. The primary inclusion criteria was both gender with age \>18years and written informed consent.

You may qualify if:

• Written informed consent
• Male or Female patient
• Age of patient ≥18 years
• Patients already diagnosed with HCV and on DAAs therapy.

You may not qualify if:

• Written informed consent
• Male or Female patient
• Age of patient ≥18 years
• Patients already diagnosed with HCV and on DAAs therapy.

Sponsors & Collaborators

• Getz Pharma: lead

Study Sites (1)

Liver Center Faisalabad

Faisalabad, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Hepatitis, Chronic

Interventions

Sofosbuvir; daclatasvir; Ribavirin; velpatasvir

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 11, 2020
• Study Start: May 15, 2018
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

PA (1)