Safety IssuesNCT04664894
Direct Acting Anti-Viral's In Chronic HCV Patients
An observational study of Safety Issues, run by Getz Pharma at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety Issues
- What is being tested?
- Sofosbuvir
- How many people
- 511 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2018to 30 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Written informed consent
- Male or Female patient
- Age of patient ≥18 years
- Patients already diagnosed with HCV and on DAAs therapy.
Who cannot join
- Written informed consent
- Male or Female patient
- Age of patient ≥18 years
- Patients already diagnosed with HCV and on DAAs therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Drugs And New Concerns: Gaining Insight Through Pharmacovigilance Of 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
Read the 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.
- Conditions
- Safety Issues
- Being tested
- Sofosbuvir
- Keywords
- adverse events, chronic hepatitis, direct acting antivirals
- Medical subject headings
- Hepatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SofosbuvirDrug
Also called Daclatasvir, Ribavirin, Velpatasvir
the occurrence of AEs (AE) and their severity among chronic HCV patients has assessed in patinets receiving different combinations of DAAs in Pakistani Population
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start15 May 2018
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Getz Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664894
- Sponsor's protocol ID
- GTZ-NLRF-001
- Status last verified
- Dec 2020
- First submitted
- 27 Nov 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Drugs And New Concerns: Gaining Insight Through Pharmacovigilance Of Direct Acting Anti-Viral's In Chronic HCV Patients
- ClinicalTrials.gov ID
- NCT04664894
- Acronym / sponsor ID
- GTZ-NLRF-001
- Conditions
- Safety Issues
- Keywords
- adverse events, chronic hepatitis, direct acting antivirals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Getz PharmaIndustry (pharma, biotech, devices)
- Study start
- 15 May 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Written informed consent
- Male or Female patient
- Age of patient ≥18 years
- Patients already diagnosed with HCV and on DAAs therapy.
Key exclusion criteria (4 listed)
- Written informed consent
- Male or Female patient
- Age of patient ≥18 years
- Patients already diagnosed with HCV and on DAAs therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SofosbuvirAlso: Daclatasvir, Ribavirin, Velpatasvirthe occurrence of AEs (AE) and their severity among chronic HCV patients has assessed in patinets receiving different combinations of DAAs in Pakistani Population | Drug | – |
Primary outcome
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
1 secondary outcome
Percentage of patients reported severity of medical event as per Karch and Lasagna classification
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety Issues, run by Getz Pharma at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.