Studies
| Study First Submitted Date | 2020-11-27 |
| Study First Posted Date | 2020-12-11 |
| Last Update Posted Date | 2020-12-11 |
| Start Month Year | May 15, 2018 |
| Primary Completion Month Year | May 30, 2019 |
| Verification Month Year | December 2020 |
| Verification Date | 2020-12-31 |
| Last Update Posted Date | 2020-12-11 |
Detailed Descriptions
| Sequence: | 20637496 |
| 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. |
Facilities
| Sequence: | 199188766 |
| Name | Liver Center Faisalabad |
| City | Faisalabad |
| State | Punjab |
| Country | Pakistan |
Browse Interventions
| Sequence: | 95637070 | Sequence: | 95637071 | Sequence: | 95637072 | Sequence: | 95637073 | Sequence: | 95637074 | Sequence: | 95637075 | Sequence: | 95637076 |
| Mesh Term | Ribavirin | Mesh Term | Sofosbuvir | Mesh Term | Velpatasvir | Mesh Term | Antimetabolites | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antiviral Agents | Mesh Term | Anti-Infective Agents |
| Downcase Mesh Term | ribavirin | Downcase Mesh Term | sofosbuvir | Downcase Mesh Term | velpatasvir | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antiviral agents | Downcase Mesh Term | anti-infective agents |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 51953236 |
| Name | Safety Issues |
| Downcase Name | safety issues |
Id Information
| Sequence: | 39989530 |
| Id Source | org_study_id |
| Id Value | GTZ-NLRF-001 |
Countries
| Sequence: | 42380449 |
| Name | Pakistan |
| Removed | False |
Interventions
| Sequence: | 52265503 |
| Intervention Type | Drug |
| Name | Sofosbuvir |
| Description | the occurrence of AEs (AE) and their severity among chronic HCV patients has assessed in patinets receiving different combinations of DAAs in Pakistani Population |
Keywords
| Sequence: | 79528677 | Sequence: | 79528678 | Sequence: | 79528679 |
| Name | adverse events | Name | chronic hepatitis | Name | direct acting antivirals |
| Downcase Name | adverse events | Downcase Name | chronic hepatitis | Downcase Name | direct acting antivirals |
Design Outcomes
| Sequence: | 176605717 | Sequence: | 176605718 | Sequence: | 176605719 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | other |
| Measure | Frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon | Measure | Percentage of patients reported severity of medical event as per Karch and Lasagna classification | Measure | Percentage of patient having serious adverse event as per ICH Classification |
| Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months |
| Description | Frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon | Description | Percentage of patients reported severity of medical event as per Karch and Lasagna classification | Description | Percentage of patient having serious adverse event as per ICH Classification |
Sponsors
| Sequence: | 48115448 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Getz Pharma |
Eligibilities
| Sequence: | 30636987 |
| Sampling Method | Non-Probability Sample |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| 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. |
| Criteria | 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. |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254131097 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2020 |
| Actual Duration | 12 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 1 |
| Number Of Other Outcomes To Measure | 1 |
Designs
| Sequence: | 30383922 |
| Observational Model | Other |
| Time Perspective | Cross-Sectional |
Intervention Other Names
| Sequence: | 26560170 | Sequence: | 26560171 | Sequence: | 26560172 |
| Intervention Id | 52265503 | Intervention Id | 52265503 | Intervention Id | 52265503 |
| Name | Daclatasvir | Name | Ribavirin | Name | Velpatasvir |
Responsible Parties
| Sequence: | 28750656 |
| Responsible Party Type | Sponsor |