Hepatitis CPhase 4NCT03313414
HCV Post-Exposure Prophylaxis for Health Care Workers
A Phase 4 study testing Sofosbuvir/Velpatasvir Treatment for 14 days in people with Hepatitis C, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is an unblinded, observational trial of sofosbuvir-velpatasvir in adult health care workers who are exposed to hepatitis C virus from needlestick injury with hollow-bore needles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Sofosbuvir/Velpatasvir Treatment for 14 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2019to 16 Jan 2020
- Phase
- Phase 4
- 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
Who may be able to join
- Healthcare worker with exposure through needlestick injury with hollow-bore needles to source patients who are HCV positive
- Healthcare worker must be HCV Ab-
Who cannot join
- HCV Ab positive
- HCV Ab negative and HCV RNA greater than 1000 IU/ml
- Active malignancy
- Positive urine pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers
This is an unblinded, observational trial of sofosbuvir-velpatasvir in adult health care workers who are exposed to hepatitis C virus from needlestick injury with hollow-bore needles.
Read the detailed description
The goal of this study is to assess the safety and tolerability of the use of sofosbuvir-velpatasvir in the setting of post-exposure prophylaxis among Health Care Workers exposed to HCV from needlestick injury with hollow-bore needles
- Conditions
- Hepatitis C
- Being tested
- Sofosbuvir/Velpatasvir Treatment for 14 days
- Keywords
- HCV, Needlestick
- Medical subject headings
- Hepatitis C, Needlestick Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir/Velpatasvir Treatment for 14 daysDrug
Also called Epclusa
14 day therapy with Sofosbuvir/Velpatasvir
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Sofosbuvir/Velpatasvir | Experimental | 14 days of treatment with Sofosbuvir/Velpatasvir tablet Receives: Drug: Sofosbuvir/Velpatasvir Treatment for 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable HCV RNA
Negative HCV viral RNA at 12 weeks after the last dose of treatment.
Measured: 12 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start13 Aug 2019
- Primary completionJan 2020 (estimated)
- Study completion16 Jan 2020
Why it stopped: No participant enrollment, funding withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Raymond Chung, Massachusetts General Hospital
- Investigators
- Raymond Chung, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313414
- Sponsor's protocol ID
- 2017P001661
- Status last verified
- Jan 2020
- First submitted
- 13 Oct 2017
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: no plan currently to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers
- ClinicalTrials.gov ID
- NCT03313414
- Acronym / sponsor ID
- 2017P001661
- Conditions
- Hepatitis C
- Keywords
- HCV, Needlestick
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participant enrollment, funding withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 18 Oct 2017 (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.
This is an unblinded, observational trial of sofosbuvir-velpatasvir in adult health care workers who are exposed to hepatitis C virus from needlestick injury with hollow-bore needles.
Detailed description
The goal of this study is to assess the safety and tolerability of the use of sofosbuvir-velpatasvir in the setting of post-exposure prophylaxis among Health Care Workers exposed to HCV from needlestick injury with hollow-bore needles
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Sofosbuvir/Velpatasvir | Experimental | Drug: Sofosbuvir/Velpatasvir Treatment for 14 days14 days of treatment with Sofosbuvir/Velpatasvir tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthcare worker with exposure through needlestick injury with hollow-bore needles to source patients who are HCV positive
- Healthcare worker must be HCV Ab-
Key exclusion criteria (4 listed)
- HCV Ab positive
- HCV Ab negative and HCV RNA greater than 1000 IU/ml
- Active malignancy
- Positive urine pregnancy test
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 |
|---|---|---|
| Sofosbuvir/Velpatasvir Treatment for 14 daysAlso: Epclusa14 day therapy with Sofosbuvir/Velpatasvir | Drug | Treatment with Sofosbuvir/Velpatasvir |
Primary outcome
Undetectable HCV RNA
Time frame: 12 weeks post treatment
Negative HCV viral RNA at 12 weeks after the last dose of treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Individual participant dataSharing planned: No. no plan currently to share IPD with other researchers
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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.
Raymond Chung, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sofosbuvir/Velpatasvir Treatment for 14 days in people with Hepatitis C, run by Massachusetts General Hospital at 1 site in United States.
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 2 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: withdrawn, as of the sponsor's last update on 21 Jan 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Undetectable HCV RNA (time frame: 12 weeks post treatment). 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 21 Jan 2020.