Hepatitis CPhase 2NCT01180790
Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants
A Phase 2 study testing ACH-0141625 (Sovaprevir), Pegylated Interferon alpha-2a and Ribavirin in people with Hepatitis C, run by Alexion Pharmaceuticals, Inc. at 18 sites in 2 countries.
Trial summary
Evaluate safety, tolerability, and antiviral response of ACH-0141625 compared to standard of care in hepatitis C virus (HCV)-positive participants. 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?
- ACH-0141625 (Sovaprevir), Pegylated Interferon alpha-2a and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Sep 2010to Apr 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males and females, aged 18 years and older
- Chronic hepatitis C genotype 1 (as specified in the protocol)
- Treatment naive
- Females who are post-menopausal and amenorrheic must have a follicle-stimulating hormone (FSH) at screening. Females of childbearing potential must have a negative pregnancy test at screening and baseline. Females must use a non-hormonal method of contraception and must agree not to get pregnant during the study and for 6 months following the discontinuation of standard of care (SOC).
- Fertile males must agree to use a condom and his female partner must agree to use 1 or more methods of contraception. Males must not donate sperm during the study and 3 months following the last exposure to RBV.
Who cannot join
- Body mass index (BMI) >36 kilograms (kg)/square meter (m^2)
- Pregnant or nursing females or females of childbearing potential not willing to comply with contraceptive measures per protocol. Men whose female partners are pregnant or contemplating pregnancy. - Coinfection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV)
- Other significant diseases including liver disease
- History of drug or alcohol dependence or addiction within the past 6 months
- History of participation in a clinical trial with a protease inhibitor or previous treatment with a protease inhibitor, where at least 1 dose of the protease inhibitor was consumed.
- Use of herbal or homeopathic products, illicit drugs, cytochrome P450 (CYP) 3A4/5 substrates, inducers or inhibitors, hormonal methods of contraception, corticosteroids, immunosuppressive, or cytotoxic agents within 28 days of the first dose of study drug.
Show all 20Show fewer
- Have a clinically significant laboratory abnormality at screening (as specified in the protocol).
- Segment 1: Participants with any history of decompensated liver disease defined as cirrhotic participants with a Child-Pugh score of > or = to 7. Segment 2: Participants who have had a liver biopsy that shows bridging fibrosis or cirrhosis.
- Nonalcoholic steatohepatitis if ballooning degeneration or Mallory bodies are present on liver biopsy.
- Participants who prematurely discontinued, interrupted, or dose reduced prior Peg-IFN and RBV therapy due to noncompliance or safety issues.
- Encephalopathy or altered mental status of any etiology.
- History of moderate, severe, or uncontrolled psychiatric disease (as specified in the protocol).
- History of malignancy of any organ system treated or untreated within the past 5 years.
- Use of colony stimulating factor agents within 90 days prior to baseline.
- History of seizure disorder.
- History of known coagulopathy including hemophilia.
- Clinically of significant findings on fundoscopic or retinal examination at screening
- History of immunologically mediate disease.
- History of clinical evidence of chronic cardiac disease (as specified in the protocol)
- Received concomitant systemic antibiotic, antifungals, or antivirals for the treatment of active infection within 14 days prior to the first dose of the study drug (as specified in the protocol)
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States15 sites
Clinical Trial Site
Arlington, Texas, 76012
Clinical Trial Site
Bradenton, Florida, 34209
Clinical Trial Site
Chicago, Illinois, 60611
Clinical Trial Site
Las Vegas, Nevada, 89106
Clinical Trial Site
Los Angeles, California, 90036
Clinical Trial Site
Los Angeles, California, 90048
Clinical Trial Site
New York, New York, 10065
Clinical Trial Site
Newport News, Virginia, 23602
Clinical Trial Site
Norfolk, Virginia, 23502
Clinical Trial Site
Orlando, Florida, 32803
Clinical Trial Site
Overland Park, Kansas, 66211
Clinical Trial Site
Philadelphia, Pennsylvania, 19141
Clinical Trial Site
San Antonio, Texas, 78215
Clinical Trial Site
San Francisco, California, 94115
Clinical Trial Site
St Louis, Missouri, 63104
Belgium3 sites
Clinical Trial Site
Edegem, Antwerp, 2650
Clinical Trial Site
Ghent, Oost-Vlaanderen, 9000
Clinical Trial Site
Haine-Saint-Paul, Hainaut, 7100
About this study
Official title: A Phase IIa, Randomized, Double-blind (Participant and Investigator Blind, Sponsor Open), Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Antiviral Activity of Oral ACH-0141625 in Combination With Pegylated Interferon Alpha-2a and Ribavirin in Two Segments, After 28 Days of Dosing and, Subsequently, After 12 Weeks of Dosing in Participants With Chronic Hepatitis C Virus Genotype 1
Evaluate safety, tolerability, and antiviral response of ACH-0141625 compared to standard of care in hepatitis C virus (HCV)-positive participants.
- Conditions
- Hepatitis C
- Being tested
- ACH-0141625 (Sovaprevir), Placebo, Pegylated Interferon alpha-2a, Ribavirin
- Keywords
- HCV, Hepatitis C Genotype 1
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACH-0141625 (Sovaprevir)Drug
200 mg oral capsule once daily
ACH-0141625 (Sovaprevir)Drug
400 mg oral capsule once daily
ACH-0141625 (Sovaprevir)Drug
800 mg oral capsule once daily
PlaceboDrug
Powder in capsule once daily
Pegylated Interferon alpha-2aDrug
Also called Peg-INF
180 micrograms (ug) once a week by subcutaneous injection
RibavirinDrug
Also called Ribasphere, Copegus
400 mg or 600 mg (morning [AM]) and 600 mg (evening [PM]) capsules taken orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Segment 1: 200 milligrams (mg) ACH-0141625 | Experimental | 200 mg ACH-0141625 for 28 days plus pegylated interferon (Peg-IFN) alpha-2a and ribavirin (RBV) for 48 weeks Receives: Drug: ACH-0141625 (Sovaprevir); Drug: Pegylated Interferon alpha-2a; Drug: Ribavirin |
| Segment 1: 400 mg ACH-0141625 | Experimental | 400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks Receives: Drug: ACH-0141625 (Sovaprevir); Drug: Pegylated Interferon alpha-2a; Drug: Ribavirin |
| Segment 1: 800 mg ACH-0141625 | Experimental | 800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks Receives: Drug: ACH-0141625 (Sovaprevir); Drug: Pegylated Interferon alpha-2a; Drug: Ribavirin |
| Segment 1: Placebo | Placebo comparator | Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks Receives: Drug: Placebo; Drug: Pegylated Interferon alpha-2a; Drug: Ribavirin |
| Segment 2: 200 mg ACH-0141625 | Experimental | 200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks Receives: Drug: ACH-0141625 (Sovaprevir); Drug: Pegylated Interferon alpha-2a; Drug: Ribavirin |
| Segment 2 : 400 mg ACH-0141625 | Experimental | 400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks Receives: Drug: ACH-0141625 (Sovaprevir); Drug: Pegylated Interferon alpha-2a; Drug: Ribavirin |
| Segment 2 : 800 mg ACH-0141625 | Experimental | 800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks Receives: Drug: ACH-0141625 (Sovaprevir); Drug: Pegylated Interferon alpha-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Segment 1: Safety
Segment 1: Percentage of participants with the following: adverse events, abnormal laboratory safety tests, dose reductions, interruptions, and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening Division of AIDS (Acquired Immunodeficiency Syndrome) (DAIDs) graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: 4 weeks
Segment 1: Rapid Viral Response At Week 4 (RVR4)
The primary efficacy endpoint for Segment 1 of the study was the percentage of participants in each treatment group achieving RVR4 (hepatitis C virus [HCV] ribonucleic acid (RNA) less than or equal to the limit of quantitation [LOQ] at the Week 4 visit).
Measured: 4 weeks
Segment 2: Safety
Segment 2: Percentage of participants with the following: adverse events, abnormal laboratory safety tests and dose reductions, interruptions and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: 12 weeks
Segment 2: Complete Early Virologic Response (cEVR)
The primary efficacy endpoint for Segment 2 of the study was the percentage of participants achieving cEVR, defined as undetectable HCV RNA at Week 12.
Measured: Week 12
Secondary outcomes (7)
Segment 1: cEVR
For Segment 1, the percentage of participants in the virology population who achieved cEVR, defined as undetectable HCV RNA at Week 12.
Measured: 12 weeks
Segment 2: RVR4
For Segment 2, the percentage of participants in the virology population who achieved RVR4, defined as HCV RNA less than or equal to the LOQ at the Week 4 visit.
Measured: 4 weeks
Segment 1 And Segment 2: End Of Treatment Response
The percentage of virology population participants who were reported as undetectable HCV RNA at the completion of treatment.
Measured: Week 48 (Segment 1); Week 24 (Segment 2)
Segment 1 And Segment 2: Sustained Virologic Response 12 Weeks (3 Months Post-dosing) (SVR12)
The percentage of virology population participants who achieved sustained virologic response (SVR), defined as HCV RNA less than the LOQ, at 12 weeks (3 months) post-dosing.
Measured: 3 months post-dosing
Segment 1 And Segment 2: Sustained Virologic Response 24 Weeks (6 Months Post-dosing) (SVR24)
The percentage of virology population participants who achieved SVR, defined as HCV RNA less than the LOQ, 6 months post-dosing.
Measured: 6 months post-dosing
Segment 1 And Segment 2: HCV RNA Change From Baseline
The mean change from baseline in log10 HCV RNA level by visit for the virology population
Measured: Week 4
Segment 1 And Segment 2: HCV RNA Change From Baseline
Change from baseline in log10 HCV RNA level by visit.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Achillion, a wholly owned subsidiary of Alexion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180790
- Sponsor's protocol ID
- ACH625-003
- Other IDs
- 2010-022092-65
- Status last verified
- Aug 2023
- First submitted
- 11 Aug 2010
- Last updated
- 30 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomized, Double-blind (Participant and Investigator Blind, Sponsor Open), Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Antiviral Activity of Oral ACH-0141625 in Combination With Pegylated Interferon Alpha-2a and Ribavirin in Two Segments, After 28 Days of Dosing and, Subsequently, After 12 Weeks of Dosing in Participants With Chronic Hepatitis C Virus Genotype 1
- ClinicalTrials.gov ID
- NCT01180790
- Acronym / sponsor ID
- ACH625-003
- Conditions
- Hepatitis C
- Keywords
- HCV, Hepatitis C Genotype 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Achillion, a wholly owned subsidiary of Alexion
- Study start
- Sep 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Aug 2010 (estimated)
- Results
- Posted 10 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate safety, tolerability, and antiviral response of ACH-0141625 compared to standard of care in hepatitis C virus (HCV)-positive participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Segment 1: 200 milligrams (mg) ACH-0141625 | Experimental | Drug: ACH-0141625 (Sovaprevir), Drug: Pegylated Interferon alpha-2a, Drug: Ribavirin200 mg ACH-0141625 for 28 days plus pegylated interferon (Peg-IFN) alpha-2a and ribavirin (RBV) for 48 weeks |
| Segment 1: 400 mg ACH-0141625 | Experimental | Drug: ACH-0141625 (Sovaprevir), Drug: Pegylated Interferon alpha-2a, Drug: Ribavirin400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks |
| Segment 1: 800 mg ACH-0141625 | Experimental | Drug: ACH-0141625 (Sovaprevir), Drug: Pegylated Interferon alpha-2a, Drug: Ribavirin800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks |
| Segment 1: Placebo | Placebo comparator | Drug: Placebo, Drug: Pegylated Interferon alpha-2a, Drug: RibavirinPlacebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks |
| Segment 2: 200 mg ACH-0141625 | Experimental | Drug: ACH-0141625 (Sovaprevir), Drug: Pegylated Interferon alpha-2a, Drug: Ribavirin200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks |
| Segment 2 : 400 mg ACH-0141625 | Experimental | Drug: ACH-0141625 (Sovaprevir), Drug: Pegylated Interferon alpha-2a, Drug: Ribavirin400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks |
| Segment 2 : 800 mg ACH-0141625 | Experimental | Drug: ACH-0141625 (Sovaprevir), Drug: Pegylated Interferon alpha-2a, Drug: Ribavirin800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females, aged 18 years and older
- Chronic hepatitis C genotype 1 (as specified in the protocol)
- Treatment naive
- Females who are post-menopausal and amenorrheic must have a follicle-stimulating hormone (FSH) at screening. Females of childbearing potential must have a negative pregnancy test at screening and baseline. Females must use a non-hormonal method of contraception and must agree not to get pregnant during the study and for 6 months following the discontinuation of standard of care (SOC).
- Fertile males must agree to use a condom and his female partner must agree to use 1 or more methods of contraception. Males must not donate sperm during the study and 3 months following the last exposure to RBV.
Key exclusion criteria (20 listed)
- Body mass index (BMI) >36 kilograms (kg)/square meter (m^2)
- Pregnant or nursing females or females of childbearing potential not willing to comply with contraceptive measures per protocol. Men whose female partners are pregnant or contemplating pregnancy. - Coinfection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV)
- Other significant diseases including liver disease
- History of drug or alcohol dependence or addiction within the past 6 months
- History of participation in a clinical trial with a protease inhibitor or previous treatment with a protease inhibitor, where at least 1 dose of the protease inhibitor was consumed.
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 |
|---|---|---|
| ACH-0141625 (Sovaprevir)200 mg oral capsule once daily | Drug | Segment 1: 200 milligrams (mg) ACH-0141625, Segment 2: 200 mg ACH-0141625 |
| ACH-0141625 (Sovaprevir)400 mg oral capsule once daily | Drug | Segment 1: 400 mg ACH-0141625, Segment 2 : 400 mg ACH-0141625 |
| ACH-0141625 (Sovaprevir)800 mg oral capsule once daily | Drug | Segment 1: 800 mg ACH-0141625, Segment 2 : 800 mg ACH-0141625 |
| PlaceboPowder in capsule once daily | Drug | Segment 1: Placebo |
| Pegylated Interferon alpha-2aAlso: Peg-INF180 micrograms (ug) once a week by subcutaneous injection | Drug | Segment 1: 200 milligrams (mg) ACH-0141625, Segment 1: 400 mg ACH-0141625, Segment 1: 800 mg ACH-0141625, Segment 1: Placebo, Segment 2 : 400 mg ACH-0141625, Segment 2 : 800 mg ACH-0141625, Segment 2: 200 mg ACH-0141625 |
| RibavirinAlso: Ribasphere, Copegus400 mg or 600 mg (morning [AM]) and 600 mg (evening [PM]) capsules taken orally twice daily | Drug | Segment 1: 200 milligrams (mg) ACH-0141625, Segment 1: 400 mg ACH-0141625, Segment 1: 800 mg ACH-0141625, Segment 1: Placebo, Segment 2 : 400 mg ACH-0141625, Segment 2 : 800 mg ACH-0141625, Segment 2: 200 mg ACH-0141625 |
Primary outcome
Segment 1: Safety
Time frame: 4 weeks
Segment 1: Percentage of participants with the following: adverse events, abnormal laboratory safety tests, dose reductions, interruptions, and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening Division of AIDS (Acquired Immunodeficiency Syndrome) (DAIDs) graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Segment 1: Rapid Viral Response At Week 4 (RVR4)
Time frame: 4 weeks
The primary efficacy endpoint for Segment 1 of the study was the percentage of participants in each treatment group achieving RVR4 (hepatitis C virus [HCV] ribonucleic acid (RNA) less than or equal to the limit of quantitation [LOQ] at the Week 4 visit).
Segment 2: Safety
Time frame: 12 weeks
Segment 2: Percentage of participants with the following: adverse events, abnormal laboratory safety tests and dose reductions, interruptions and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Segment 2: Complete Early Virologic Response (cEVR)
Time frame: Week 12
The primary efficacy endpoint for Segment 2 of the study was the percentage of participants achieving cEVR, defined as undetectable HCV RNA at Week 12.
7 secondary outcomes
Segment 1: cEVR
Time frame: 12 weeks
Segment 2: RVR4
Time frame: 4 weeks
Segment 1 And Segment 2: End Of Treatment Response
Time frame: Week 48 (Segment 1); Week 24 (Segment 2)
Segment 1 And Segment 2: Sustained Virologic Response 12 Weeks (3 Months Post-dosing) (SVR12)
Time frame: 3 months post-dosing
Segment 1 And Segment 2: Sustained Virologic Response 24 Weeks (6 Months Post-dosing) (SVR24)
Time frame: 6 months post-dosing
Segment 1 And Segment 2: HCV RNA Change From Baseline
Time frame: Week 4
Segment 1 And Segment 2: HCV RNA Change From Baseline
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACH-0141625 (Sovaprevir), Pegylated Interferon alpha-2a and Ribavirin in people with Hepatitis C, run by Alexion Pharmaceuticals, Inc. at 18 sites in 2 countries.
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 5 inclusion and 20 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 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Belgium. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Segment 1: Safety (time frame: 4 weeks). The study lists 4 primary outcomes in all. 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 30 Aug 2023.