Direct Acting Anti-Viral's In Chronic HCV Patients

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04664894
• Other study ID #: GTZ-NLRF-001
• Status: Completed
• Start date: May 15, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: December 2020
• Source: Getz Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent

2. Male or Female patient

3. Age of patient =18 years

4. Patients already diagnosed with HCV and on DAAs therapy.

Exclusion Criteria:

1. Written informed consent

2. Male or Female patient

3. Age of patient =18 years

4. Patients already diagnosed with HCV and on DAAs therapy.

Related Conditions & MeSH terms

• Safety Issues

Intervention

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

Locations

Country	Name	City	State
Pakistan	Liver Center Faisalabad	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Getz Pharma

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of patient having serious adverse event as per ICH Classification	Percentage of patient having serious adverse event as per ICH Classification	12 months
Primary	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	Percentage of patients reported severity of medical event as per Karch and Lasagna classification	Percentage of patients reported severity of medical event as per Karch and Lasagna classification	12 months