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OpenTrials
Completed

NCT Number: NCT04664894

Direct Acting Anti-Viral's In Chronic HCV Patients

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Liver Center Faisalabad

Faisalabad, Punjab Province, Pakistan

About this study

The cross sectional survey data will be collected on a pre-defined questionnaire from Gastroenterologist and Hepatologist. The questionnaire will provide us information on demographics, relevant patient history, concomitant medication, ongoing treatment plan recommended for chronic HCV and adverse event details.

The questions related to Pharmacovigilance and safety assessment includes the International Nonproprietary Names (INN) unless it is prescribed brand of Getz Pharma. All adverse events associated with the prescribed treatment will be recorded. Data on outcome assessment will be based on action taken due to AE and other reported details. Seriousness of adverse event will also be recorded as per the ICH classification and severity of medical event will be assessed as per Karch and Lasagna classification.

All the information will be recorded by the healthcare professionals on the questionnaire during direct interaction with the patients.

Patients' written authorization to use and/or disclose the patient's personal and/or health data will be obtained. However, patient data secrecy will follow ICH GCP requirements.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Other names: Daclatasvir, Ribavirin, Velpatasvir

Primary outcomes

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

    Time frame: 12 months

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

Secondary outcomes

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

    Time frame: 12 months

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

Other outcomes

  1. Percentage of patient having serious adverse event as per ICH Classification

    Time frame: 12 months

    Percentage of patient having serious adverse event as per ICH Classification

Sponsors and collaborators

Lead sponsor

Getz Pharma

Industry

Registry information

Official study title

New Drugs And New Concerns: Gaining Insight Through Pharmacovigilance Of Direct Acting Anti-Viral's In Chronic HCV Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 11, 2020
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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