Safety Issues
Conditions
Keywords
adverse events, chronic hepatitis, direct acting antivirals
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.
Interventions
DRUGSofosbuvir
the occurrence of AEs (AE) and their severity among chronic HCV patients has assessed in patinets receiving different combinations of DAAs in Pakistani Population
Sponsors
Getz Pharma
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon | 12 months | Frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients reported severity of medical event as per Karch and Lasagna classification | 12 months | Percentage of patients reported severity of medical event as per Karch and Lasagna classification |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patient having serious adverse event as per ICH Classification | 12 months | Percentage of patient having serious adverse event as per ICH Classification |
Countries
Pakistan
Outcome results
None listed