Clinical trial NCT04664894: Direct Acting Anti-Viral's In Chronic HCV Patients
Official title: New Drugs And New Concerns: Gaining Insight Through Pharmacovigilance Of Direct Acting Anti-Viral's In Chronic HCV Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Safety Issues
Keywords: adverse events
chronic hepatitis
direct acting antivirals
Lead sponsor: Getz Pharma
Sponsor class: INDUSTRY
First posted: 2020-12-11
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of patients reported severity of medical event as per Karch and Lasagna classification
timeFrame: 12 months
Other outcomes:
measure: Percentage of patient having serious adverse event as per ICH Classification
timeFrame: 12 months
Locations:
city: Faisalabad
country: Pakistan
facility: Liver Center Faisalabad
state: Punjab
Study officials:
References: