Hepatitis CPhase 1/2NCT01441180
GS-7977 With Ribavirin for Hepatitis C (SPARE)
A Phase 1/2 study testing GS7977 and RBV in people with Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: GS-7977 is a new drug that is being developed to treat hepatitis C infection. It works by blocking the hepatitis C virus from dividing in the body. This medication has been used along with other medications commonly used to treat hepatitis C, such as interferon and ribavirin. 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?
- GS7977 and RBV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jul 2014
- Phase
- Phase 1/2
- 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
None listed.
Who cannot join
- Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab.
- History of any other clinically significant chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, Wilson s disease, greater than or equal to 1-antitrypsin deficiency, alcoholic liver disease, > Grade 1 Stage 1 non-alcoholic steatohepatitis and toxin exposures).
- Treatment with unlicensed herbal/natural remedies suggested to be taken for hepatitis treatment such as Milk thistle or Cats Claw within 28 days of Day 0.
- Participants with a history of ascites, variceal hemorrhage, hepatic encephalopathy, or conditions consistent with decompensated liver disease.
- Screening or baseline ECG with clinically significant ECG findings.
- A personal history of or first degree relative with a history of Torsade de pointes.
Show all 26Show fewer
- Any substance detected during the screening process that, in the opinion of the investigator, is thought to affect protocol compliance or drug metabolism and disposition.
- Abnormal hematological and biochemical parameters, including:
- Neutrophil count < 1000 cells/mm(3)
- Hemoglobin < 11 g/dL in women and < 12 g/dL in men
- Platelet count less than or equal to 75,000 cells/mm(3)
- Estimated GFR, calculated by the CKD-EPI equation, < 50 mL/min/ per 1.73 m(2)
- ALT or AST greater than or equal to 10 times ULN
- Serum lipase greater than or equal to 1.5 times ULN (at Screening or during the Screening period)
- Total bilirubin greater than or equal to 2.0 times ULN (except in subjects with Gilbert s syndrome)
- Albumin less than or equal to 3.0 g/dL
- History of major organ transplantation with an existing functional graft.
- History of uncontrolled thyroid disease or abnormal TSH levels as defined < 0.8 times LLN or > 1.2 times ULN at Screening.
- Fasting blood glucose greater than or equal to 300 mg/dl or HbA1C greater than 9.
- Donation or loss of more than 400 mL blood within 8 weeks prior to first dose administration.
- History of clinically significant drug allergy to nucleoside/nucleotide analogs.
- History or current evidence of psychiatric illness, immunologic disorder, pulmonary, cardiac disease, seizure disorder, cancer or history of malignancy that in the opinion of the investigator makes the patient unsuitable for the study. Chronic medical conditions, especially if treated with medications (such as hypertension), must be stable at the time of screening. No new therapies should be started prior to the study that may confound the assessment of study drug safety.
- History of having received any systemic antineoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids > 10 mg/day for more than 6 weeks, and radiation) within 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
- Participation in a clinical study in which an investigational drug, biologic, or device was received within 12 weeks prior to first dose administration.
- Pregnant/Breastfeeding women or men whose partners are currently pregnant.
- Known hypersensitivity to RBV, study investigational medicinal products or metabolites.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Randomized Controlled Study To Assess Safety, Tolerability And Efficacy Of GS-7977 In Combination With Full or Low Dose RBV In HCV Genotype 1, Monoinfected Treatment Naive Participants
Background:
- GS-7977 is a new drug that is being developed to treat hepatitis C infection. It works by blocking the hepatitis C virus from dividing in the body. This medication has been used along with other medications commonly used to treat hepatitis C, such as interferon and ribavirin. When used with interferon and ribavirin, GS-7977 seems to be very effective in eliminating the hepatitis C virus from the body. However, interferon can have serious side effects, so researchers want to see if GS-7977 can work by itself or with only ribavirin.
Read more
Objectives:
- To test the safety and effectiveness of GS-7977 alone or given with ribavirin for hepatitis C infection.
Eligibility:
- Individuals at least 18 years of age who have hepatitis C with liver disease, and have never received drugs for it.
Design:
- This study will require multiple clinic visits over 18 months. A liver biopsy will be required before the start of the study if participants have not had one within the past 3 years.
- Participants will be screened with a medical history and physical exam.
- Participants will have either GS-7977 alone or GS-7977 with ribavirin. GS-7977 is taken by mouth once a day. Ribavirin is taken by mouth in the morning and evening.
- Participants will have study visits on Days 1, 3, 5, 7, 10, and 14. These visits will involve regular blood tests and symptom monitoring.
- After the second week, participants will have study visits during Weeks 3, 4, 6, 8, 12, 16, and 20. Blood and urine tests will be given to study virus levels in the body, and symptoms will be discussed.
- Participants will stop receiving the study drugs at Week 24.
- Followup clinic visits with blood tests will take place in Weeks 28, 36, 48, 52, 60, and 72. Another liver biopsy will be performed at 48 weeks.
- Some participants may also be part of a smaller study. This study involves frequent blood draws to study drug and virus levels in the blood. The study will require a 36-hour hospital inpatient visit.
Read the detailed description
Chronic hepatitis C virus (HCV) infection is a major public health problem with an estimated 180 million people infected worldwide. In the United States an estimated 4.1 million people are infected and HCV is the principal cause of death from liver disease and leading indication for liver transplantation. A combination of ribavirin (RBV) and pegylated interferon (PegIFN) is the currently recommended therapy for chronic HCV infection and this may achieve viral clearance in 19% to 52% of patients infected with HCV genotype 1 (GT-1) and in 76% -80% of patients infected with HCV genotypes 2 and 3. The standard of care is changing and will soon become an HCV protease inhibitor [Boceprevir/ Telaprevir in combination with PegIFN and RBV]. The registration studies for the new protease inhibitors demonstrated increased sustained virologic response (SVR) rates of 60 70%. However, this is still associated with a high incidence of adverse events (AEs) and lower cure rates in several populations. Novel therapies that do not rely on an Interferon backbone will be required to enhance cure rates in various populations.
This is a randomized controlled open-label study to assess safety, tolerability and efficacy of GS-7977 (a potent and selective HCV NS5B inhibitor) given at a dose of 400 mg daily in combination with RBV to a total of 60 treatment-na(SqrRoot) ve HCV genotype 1 mono-infected individuals with less than or equal to stage 2 fibrosis.
The findings from this study will aid in the understanding of antiviral and host responses to an interferon (IFN) free regimen as well as determine the role of RBV in IFN-free therapies.
- Conditions
- Hepatitis C
- Being tested
- GS7977, RBV
- Keywords
- Direct Acting Antiviral, Liver, Hepatitis C, HCV
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS7977Drug
Also called sofosbuvir
drug intervention
RBVDrug
Also called ribasphere, ribapak
drug intervention
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | Participants (N =10) will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment. Receives: Drug: GS7977; Drug: RBV |
| Phase 2 Arm A | Active comparator | (N =25) 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg) Receives: Drug: GS7977; Drug: RBV |
| Phase 2 Arm B | Active comparator | (N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg). Receives: Drug: GS7977; Drug: RBV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Adverse Events
Number of participants with Grade 3-4 Adverse Events During the Study Treatment Period as a measure of safety and tolerability.
Measured: 24 weeks
Sustained Virologic Response
Sustained virology response at 24 weeks post treatment completion
Measured: 24 weeks post treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2013
- Study completionJul 2014
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.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Shyamasundaran Kottilil, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441180
- Sponsor's protocol ID
- 110258
- Other IDs
- 11-I-0258
- Status last verified
- Sep 2014
- First submitted
- 24 Sep 2011
- Last updated
- 26 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006 May 16;144(10):705-14. doi: 10.7326/0003-4819-144-10-200605160-00004.
PubMed 16702586Kim WR. The burden of hepatitis C in the United States. Hepatology. 2002 Nov;36(5 Suppl 1):S30-4. doi: 10.1053/jhep.2002.36791.
PubMed 12407574Kim WR, Brown RS Jr, Terrault NA, El-Serag H. Burden of liver disease in the United States: summary of a workshop. Hepatology. 2002 Jul;36(1):227-42. doi: 10.1053/jhep.2002.34734. No abstract available.
PubMed 12085369Sidharthan S, Kohli A, Sims Z, Nelson A, Osinusi A, Masur H, Kottilil S. Utility of hepatitis C viral load monitoring on direct-acting antiviral therapy. Clin Infect Dis. 2015 Jun 15;60(12):1743-51. doi: 10.1093/cid/civ170. Epub 2015 Mar 2.
PubMed 25733369Meissner EG, Wu D, Osinusi A, Bon D, Virtaneva K, Sturdevant D, Porcella S, Wang H, Herrmann E, McHutchison J, Suffredini AF, Polis M, Hewitt S, Prokunina-Olsson L, Masur H, Fauci AS, Kottilil S. Endogenous intrahepatic IFNs and association with IFN-free HCV treatment outcome. J Clin Invest. 2014 Aug;124(8):3352-63. doi: 10.1172/JCI75938. Epub 2014 Jul 1.
PubMed 24983321Osinusi A, Meissner EG, Lee YJ, Bon D, Heytens L, Nelson A, Sneller M, Kohli A, Barrett L, Proschan M, Herrmann E, Shivakumar B, Gu W, Kwan R, Teferi G, Talwani R, Silk R, Kotb C, Wroblewski S, Fishbein D, Dewar R, Highbarger H, Zhang X, Kleiner D, Wood BJ, Chavez J, Symonds WT, Subramanian M, McHutchison J, Polis MA, Fauci AS, Masur H, Kottilil S. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial. JAMA. 2013 Aug 28;310(8):804-11. doi: 10.1001/jama.2013.109309.
PubMed 23982366
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study To Assess Safety, Tolerability And Efficacy Of GS-7977 In Combination With Full or Low Dose RBV In HCV Genotype 1, Monoinfected Treatment Naive Participants
- ClinicalTrials.gov ID
- NCT01441180
- Acronym / sponsor ID
- 110258
- Conditions
- Hepatitis C
- Keywords
- Direct Acting Antiviral, Liver, Hepatitis C, HCV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Sep 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Posted 26 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- GS-7977 is a new drug that is being developed to treat hepatitis C infection. It works by blocking the hepatitis C virus from dividing in the body. This medication has been used along with other medications commonly used to treat hepatitis C, such as interferon and ribavirin. When used with interferon and ribavirin, GS-7977 seems to be very effective in eliminating the hepatitis C virus from the body. However, interferon can have serious side effects, so researchers want to see if GS-7977 can work by itself or with only ribavirin.
Objectives:
- To test the safety and effectiveness of GS-7977 alone or given with ribavirin for hepatitis C infection.
Eligibility:
- Individuals at least 18 years of age who have hepatitis C with liver disease, and have never received drugs for it.
Design:
- This study will require multiple clinic visits over 18 months. A liver biopsy will be required before the start of the study if participants have not had one within the past 3 years.
- Participants will be screened with a medical history and physical exam.
- Participants will have either GS-7977 alone or GS-7977 with ribavirin. GS-7977 is taken by mouth once a day. Ribavirin is taken by mouth in the morning and evening.
- Participants will have study visits on Days 1, 3, 5, 7, 10, and 14. These visits will involve regular blood tests and symptom monitoring.
- After the second week, participants will have study visits during Weeks 3, 4, 6, 8, 12, 16, and 20. Blood and urine tests will be given to study virus levels in the body, and symptoms will be discussed.
- Participants will stop receiving the study drugs at Week 24.
- Followup clinic visits with blood tests will take place in Weeks 28, 36, 48, 52, 60, and 72. Another liver biopsy will be performed at 48 weeks.
- Some participants may also be part of a smaller study. This study involves frequent blood draws to study drug and virus levels in the blood. The study will require a 36-hour hospital inpatient visit.
Detailed description
Chronic hepatitis C virus (HCV) infection is a major public health problem with an estimated 180 million people infected worldwide. In the United States an estimated 4.1 million people are infected and HCV is the principal cause of death from liver disease and leading indication for liver transplantation. A combination of ribavirin (RBV) and pegylated interferon (PegIFN) is the currently recommended therapy for chronic HCV infection and this may achieve viral clearance in 19% to 52% of patients infected with HCV genotype 1 (GT-1) and in 76% -80% of patients infected with HCV genotypes 2 and 3. The standard of care is changing and will soon become an HCV protease inhibitor [Boceprevir/ Telaprevir in combination with PegIFN and RBV]. The registration studies for the new protease inhibitors demonstrated increased sustained virologic response (SVR) rates of 60 70%. However, this is still associated with a high incidence of adverse events (AEs) and lower cure rates in several populations. Novel therapies that do not rely on an Interferon backbone will be required to enhance cure rates in various populations.
This is a randomized controlled open-label study to assess safety, tolerability and efficacy of GS-7977 (a potent and selective HCV NS5B inhibitor) given at a dose of 400 mg daily in combination with RBV to a total of 60 treatment-na(SqrRoot) ve HCV genotype 1 mono-infected individuals with less than or equal to stage 2 fibrosis.
The findings from this study will aid in the understanding of antiviral and host responses to an interferon (IFN) free regimen as well as determine the role of RBV in IFN-free therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Drug: GS7977, Drug: RBVParticipants (N =10) will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment. |
| Phase 2 Arm A | Active comparator | Drug: GS7977, Drug: RBV(N =25) 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg) |
| Phase 2 Arm B | Active comparator | Drug: GS7977, Drug: RBV(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (26 listed)
- Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab.
- History of any other clinically significant chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, Wilson s disease, greater than or equal to 1-antitrypsin deficiency, alcoholic liver disease, > Grade 1 Stage 1 non-alcoholic steatohepatitis and toxin exposures).
- Treatment with unlicensed herbal/natural remedies suggested to be taken for hepatitis treatment such as Milk thistle or Cats Claw within 28 days of Day 0.
- Participants with a history of ascites, variceal hemorrhage, hepatic encephalopathy, or conditions consistent with decompensated liver disease.
- Screening or baseline ECG with clinically significant ECG findings.
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 |
|---|---|---|
| GS7977Also: sofosbuvirdrug intervention | Drug | Phase 1, Phase 2 Arm A, Phase 2 Arm B |
| RBVAlso: ribasphere, ribapakdrug intervention | Drug | Phase 1, Phase 2 Arm A, Phase 2 Arm B |
Primary outcome
Participants With Adverse Events
Time frame: 24 weeks
Number of participants with Grade 3-4 Adverse Events During the Study Treatment Period as a measure of safety and tolerability.
Sustained Virologic Response
Time frame: 24 weeks post treatment completion
Sustained virology response at 24 weeks post treatment completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16702586Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006 May 16;144(10):705-14. doi: 10.7326/0003-4819-144-10-200605160-00004.
- Background: PubMed 12407574Kim WR. The burden of hepatitis C in the United States. Hepatology. 2002 Nov;36(5 Suppl 1):S30-4. doi: 10.1053/jhep.2002.36791.
- Background: PubMed 12085369Kim WR, Brown RS Jr, Terrault NA, El-Serag H. Burden of liver disease in the United States: summary of a workshop. Hepatology. 2002 Jul;36(1):227-42. doi: 10.1053/jhep.2002.34734. No abstract available.
- Derived from this study: PubMed 25733369Sidharthan S, Kohli A, Sims Z, Nelson A, Osinusi A, Masur H, Kottilil S. Utility of hepatitis C viral load monitoring on direct-acting antiviral therapy. Clin Infect Dis. 2015 Jun 15;60(12):1743-51. doi: 10.1093/cid/civ170. Epub 2015 Mar 2.
- Derived from this study: PubMed 24983321Meissner EG, Wu D, Osinusi A, Bon D, Virtaneva K, Sturdevant D, Porcella S, Wang H, Herrmann E, McHutchison J, Suffredini AF, Polis M, Hewitt S, Prokunina-Olsson L, Masur H, Fauci AS, Kottilil S. Endogenous intrahepatic IFNs and association with IFN-free HCV treatment outcome. J Clin Invest. 2014 Aug;124(8):3352-63. doi: 10.1172/JCI75938. Epub 2014 Jul 1.
- Derived from this study: PubMed 23982366Osinusi A, Meissner EG, Lee YJ, Bon D, Heytens L, Nelson A, Sneller M, Kohli A, Barrett L, Proschan M, Herrmann E, Shivakumar B, Gu W, Kwan R, Teferi G, Talwani R, Silk R, Kotb C, Wroblewski S, Fishbein D, Dewar R, Highbarger H, Zhang X, Kleiner D, Wood BJ, Chavez J, Symonds WT, Subramanian M, McHutchison J, Polis MA, Fauci AS, Masur H, Kottilil S. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial. JAMA. 2013 Aug 28;310(8):804-11. doi: 10.1001/jama.2013.109309.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Shyamasundaran Kottilil, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GS7977 and RBV in people with Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 0 inclusion and 26 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 26 Sep 2014. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 26 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?
Participants With Adverse Events (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01441180, which also lists 6 linked publications.
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 26 Sep 2014.