Chronic Hepatitis CPhase 4NCT00540345
Four Arms, Multicenter Study of Tailored Regimens With Peginterferon Plus Ribavirin for Genotype 2 Chronic Hepatitis C
A Phase 4 study testing pegylated interferon alpha 2a and plus ribavirin, Pegylated interferon alfa-2a and ribavirin and pegylated interferon alpha 2a and ribavirin in people with Chronic Hepatitis C, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The purposes of this study are: 1. To evaluate the efficacy and safety of low-dose versus standard-dose of ribavirin in combination with peginterferon alfa-2a given for 16 weeks in hepatitis C virus (HCV) genotype 2 infected, treatment-naïve chronic hepatitis C patients after achieving a rapid virologic response… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- pegylated interferon alpha 2a and plus ribavirin, Pegylated interferon alfa-2a and ribavirin and pegylated interferon alpha 2a and ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2006to Dec 2013
- 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
- Male and female patients 18 years of age
- Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
- Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- Detectable serum HCV-RNA and HCV viral genotype 2
- Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
- Compensated liver disease (Child-Pugh Grade A clinical classification)
- Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
- All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end
Who cannot join
- Women with ongoing pregnancy or breast feeding
- Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
- Any investigational drug 6 weeks prior to the first dose of study drug
- Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
- History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- Signs or symptoms of hepatocellular carcinoma
Show all 20Show fewer
- History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- Neutrophil count < 1500 cells/mm3 or platelet count < 90,000 cells/mm3 at screening
- Serum creatinine level > 1.5 times the upper limit of normal at screening
- History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
- History of a severe seizure disorder or current anticonvulsant use
- History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
- Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
- Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- Male partners of women who are pregnant
- Hgb < 11 g/dL in women or < 12 g/dL in men at screening
- Any patient with major thalassemia
- Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Four Arms, Multicenter, Open Label Study of Tailored Regimens With Peginterferon Plus Ribavirin for Genotype 2 Chronic Hepatitis C
The purposes of this study are:
- To evaluate the efficacy and safety of low-dose versus standard-dose of ribavirin in combination with peginterferon alfa-2a given for 16 weeks in hepatitis C virus (HCV) genotype 2 infected, treatment-naïve chronic hepatitis C patients after achieving a rapid virologic response (RVR,defined as seronegativity of HCV RNA at week 4 of treatment).
- To evaluate the efficacy and safety of 24-week versus 48-week regimen of peginterferon alfa-2a plus standard-dose of ribavirin in HCV genotype 2 infected, treatment-naïve chronic hepatitis C patients who have no RVR.
Read the detailed description
The recommended regimen for treating HCV genotype 2 patients is peginterferon plus low dose ribavirin (800 mg/day) for 24 weeks. Recently studies have demonstrated that a shorter treatment duration of 12-16 weeks of peginterferon plus standard weight-based dose of ribavirin (800-1400 mg/day) is as effective as a 24-week regimen among HCV genotype 2 patients with a RVR at week 4 of treatment (rate of sustained virological response, SVR, approximately 90%). However, for patients without a RVR at week 4 the efficacy of 24 week treatment remains unsatisfied. Individualized therapy with tailored regimen according to baseline and on-treatment virological factors, without compromising efficacy, is the future strategy in the management of chronic hepatitis C.
The aims of the present study are
- To evaluate the efficacy and safety of low-dose versus standard-dose of ribavirin in combination with peginterferon alfa-2a given for 16 weeks in hepatitis C virus (HCV) genotype 2 infected, treatment-naïve chronic hepatitis C patients after achieving a rapid virologic response (RVR,defined as seronegativity of HCV RNA at week 4 of treatment).
- To evaluate the efficacy and safety of 24-week versus 48-week regimen of peginterferon alfa-2a plus standard-dose of ribavirin in HCV genotype 2 infected, treatment-naïve chronic hepatitis C patients who have no RVR.
- Conditions
- Chronic Hepatitis C
- Being tested
- pegylated interferon alpha 2a and plus ribavirin, Pegylated interferon alfa-2a and ribavirin, pegylated interferon alpha 2a and ribavirin
- Keywords
- chronic hepatitis C, genotype 2, rapid virological response, sustained virological response, peginterferon, ribavirin, treatment duration
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated interferon alpha 2a and plus ribavirinDrug
Also called PEGASYS®
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 4 weeks followed by pegylated interferon alpha 2a 180 mcg/week and Ribavirin 800 mg/day for 12 weeks, follow up for 24 weeks
Pegylated interferon alfa-2a and ribavirinDrug
Also called PEGASYS®
pegylated interferon alfa-2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 16 weeks, follow up for 24 weeks
pegylated interferon alpha 2a and ribavirinDrug
Also called PEGASYS®
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
pegylated interferon alpha 2a and ribavirinDrug
Also called PEGASYS®
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 48 weeks, follow up for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| A, RVR LD RBV | Active comparator | Patients who have a RVR will be randomized into two groups with a ratio of 1:1 (Arm A \& B)B, RVR SD RBV A, RVR LD RBV B, RVR SD RBV Receives: Drug: pegylated interferon alpha 2a and plus ribavirin |
| B, RVR SD RBV | Active comparator | Patients who have a RVR will be randomized into two groups with a ratio of 1:1 (Arm A \& B)B, RVR SD RBV Receives: Drug: Pegylated interferon alfa-2a and ribavirin |
| C, non-RVR 24w | Active comparator | For patients who do not have a RVR will be randomized into two groups with a ratio of 1:1 (Arm C \& D) (C, non-RVR 24w) (D, non-RVR 48w) Receives: Drug: pegylated interferon alpha 2a and ribavirin |
| D, non-RVR 48w | Active comparator | For patients who do not have a RVR will be randomized into two groups with a ratio of 1:1 (Arm C \& D)(C, non-RVR 24w) (D, non-RVR 48w) Receives: Drug: pegylated interferon alpha 2a and ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4 Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period
Measured: 1.5 year
Secondary outcomes (1)
Safety - adverse event rate and profile
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startOct 2006
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MING-LUNG,YU, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Ming-Lung Yu, MD, PhD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540345
- Sponsor's protocol ID
- KMUH-IRB-960057
- Status last verified
- Dec 2014
- First submitted
- 5 Oct 2007
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mangia A, Santoro R, Minerva N, Ricci GL, Carretta V, Persico M, Vinelli F, Scotto G, Bacca D, Annese M, Romano M, Zechini F, Sogari F, Spirito F, Andriulli A. Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2005 Jun 23;352(25):2609-17. doi: 10.1056/NEJMoa042608.
PubMed 15972867Dalgard O, Bjoro K, Hellum KB, Myrvang B, Ritland S, Skaug K, Raknerud N, Bell H. Treatment with pegylated interferon and ribavarin in HCV infection with genotype 2 or 3 for 14 weeks: a pilot study. Hepatology. 2004 Dec;40(6):1260-5. doi: 10.1002/hep.20467.
PubMed 15558712von Wagner M, Huber M, Berg T, Hinrichsen H, Rasenack J, Heintges T, Bergk A, Bernsmeier C, Haussinger D, Herrmann E, Zeuzem S. Peginterferon-alpha-2a (40KD) and ribavirin for 16 or 24 weeks in patients with genotype 2 or 3 chronic hepatitis C. Gastroenterology. 2005 Aug;129(2):522-7. doi: 10.1016/j.gastro.2005.05.008.
PubMed 16083709Yu ML, Dai CY, Huang JF, Hou NJ, Lee LP, Hsieh MY, Chiu CF, Lin ZY, Chen SC, Hsieh MY, Wang LY, Chang WY, Chuang WL. A randomised study of peginterferon and ribavirin for 16 versus 24 weeks in patients with genotype 2 chronic hepatitis C. Gut. 2007 Apr;56(4):553-9. doi: 10.1136/gut.2006.102558. Epub 2006 Sep 6.
PubMed 16956917Strader DB, Wright T, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C. Hepatology. 2004 Apr;39(4):1147-71. doi: 10.1002/hep.20119. No abstract available.
PubMed 15057920
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four Arms, Multicenter, Open Label Study of Tailored Regimens With Peginterferon Plus Ribavirin for Genotype 2 Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00540345
- Acronym / sponsor ID
- KMUH-IRB-960057
- Conditions
- Chronic Hepatitis C
- Keywords
- chronic hepatitis C, genotype 2, rapid virological response, sustained virological response, peginterferon, ribavirin, treatment duration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Oct 2007 (estimated)
- 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 purposes of this study are:
- To evaluate the efficacy and safety of low-dose versus standard-dose of ribavirin in combination with peginterferon alfa-2a given for 16 weeks in hepatitis C virus (HCV) genotype 2 infected, treatment-naïve chronic hepatitis C patients after achieving a rapid virologic response (RVR,defined as seronegativity of HCV RNA at week 4 of treatment).
- To evaluate the efficacy and safety of 24-week versus 48-week regimen of peginterferon alfa-2a plus standard-dose of ribavirin in HCV genotype 2 infected, treatment-naïve chronic hepatitis C patients who have no RVR.
Detailed description
The recommended regimen for treating HCV genotype 2 patients is peginterferon plus low dose ribavirin (800 mg/day) for 24 weeks. Recently studies have demonstrated that a shorter treatment duration of 12-16 weeks of peginterferon plus standard weight-based dose of ribavirin (800-1400 mg/day) is as effective as a 24-week regimen among HCV genotype 2 patients with a RVR at week 4 of treatment (rate of sustained virological response, SVR, approximately 90%). However, for patients without a RVR at week 4 the efficacy of 24 week treatment remains unsatisfied. Individualized therapy with tailored regimen according to baseline and on-treatment virological factors, without compromising efficacy, is the future strategy in the management of chronic hepatitis C.
The aims of the present study are
- To evaluate the efficacy and safety of low-dose versus standard-dose of ribavirin in combination with peginterferon alfa-2a given for 16 weeks in hepatitis C virus (HCV) genotype 2 infected, treatment-naïve chronic hepatitis C patients after achieving a rapid virologic response (RVR,defined as seronegativity of HCV RNA at week 4 of treatment).
- To evaluate the efficacy and safety of 24-week versus 48-week regimen of peginterferon alfa-2a plus standard-dose of ribavirin in HCV genotype 2 infected, treatment-naïve chronic hepatitis C patients who have no RVR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A, RVR LD RBV | Active comparator | Drug: pegylated interferon alpha 2a and plus ribavirinPatients who have a RVR will be randomized into two groups with a ratio of 1:1 (Arm A \& B)B, RVR SD RBV A, RVR LD RBV B, RVR SD RBV |
| B, RVR SD RBV | Active comparator | Drug: Pegylated interferon alfa-2a and ribavirinPatients who have a RVR will be randomized into two groups with a ratio of 1:1 (Arm A \& B)B, RVR SD RBV |
| C, non-RVR 24w | Active comparator | Drug: pegylated interferon alpha 2a and ribavirinFor patients who do not have a RVR will be randomized into two groups with a ratio of 1:1 (Arm C \& D) (C, non-RVR 24w) (D, non-RVR 48w) |
| D, non-RVR 48w | Active comparator | Drug: pegylated interferon alpha 2a and ribavirinFor patients who do not have a RVR will be randomized into two groups with a ratio of 1:1 (Arm C \& D)(C, non-RVR 24w) (D, non-RVR 48w) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female patients 18 years of age
- Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
- Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- Detectable serum HCV-RNA and HCV viral genotype 2
- Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
Key exclusion criteria (20 listed)
- Women with ongoing pregnancy or breast feeding
- Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
- Any investigational drug 6 weeks prior to the first dose of study drug
- Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
- History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
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 |
|---|---|---|
| pegylated interferon alpha 2a and plus ribavirinAlso: PEGASYS®pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 4 weeks followed by pegylated interferon alpha 2a 180 mcg/week and Ribavirin 800 mg/day for 12 weeks, follow up for 24 weeks | Drug | A, RVR LD RBV |
| Pegylated interferon alfa-2a and ribavirinAlso: PEGASYS®pegylated interferon alfa-2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 16 weeks, follow up for 24 weeks | Drug | B, RVR SD RBV |
| pegylated interferon alpha 2a and ribavirinAlso: PEGASYS®pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks | Drug | C, non-RVR 24w |
| pegylated interferon alpha 2a and ribavirinAlso: PEGASYS®pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 48 weeks, follow up for 24 weeks | Drug | D, non-RVR 48w |
Primary outcome
Efficacy - Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4 Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period
Time frame: 1.5 year
1 secondary outcome
Safety - adverse event rate and profile
Time frame: 1.5 year
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 30 Dec 2014.
- Background: PubMed 15972867Mangia A, Santoro R, Minerva N, Ricci GL, Carretta V, Persico M, Vinelli F, Scotto G, Bacca D, Annese M, Romano M, Zechini F, Sogari F, Spirito F, Andriulli A. Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2005 Jun 23;352(25):2609-17. doi: 10.1056/NEJMoa042608.
- Background: PubMed 15558712Dalgard O, Bjoro K, Hellum KB, Myrvang B, Ritland S, Skaug K, Raknerud N, Bell H. Treatment with pegylated interferon and ribavarin in HCV infection with genotype 2 or 3 for 14 weeks: a pilot study. Hepatology. 2004 Dec;40(6):1260-5. doi: 10.1002/hep.20467.
- Background: PubMed 16083709von Wagner M, Huber M, Berg T, Hinrichsen H, Rasenack J, Heintges T, Bergk A, Bernsmeier C, Haussinger D, Herrmann E, Zeuzem S. Peginterferon-alpha-2a (40KD) and ribavirin for 16 or 24 weeks in patients with genotype 2 or 3 chronic hepatitis C. Gastroenterology. 2005 Aug;129(2):522-7. doi: 10.1016/j.gastro.2005.05.008.
- Background: PubMed 16956917Yu ML, Dai CY, Huang JF, Hou NJ, Lee LP, Hsieh MY, Chiu CF, Lin ZY, Chen SC, Hsieh MY, Wang LY, Chang WY, Chuang WL. A randomised study of peginterferon and ribavirin for 16 versus 24 weeks in patients with genotype 2 chronic hepatitis C. Gut. 2007 Apr;56(4):553-9. doi: 10.1136/gut.2006.102558. Epub 2006 Sep 6.
- Background: PubMed 15057920Strader DB, Wright T, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C. Hepatology. 2004 Apr;39(4):1147-71. doi: 10.1002/hep.20119. No abstract available.
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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.
Ming-Lung Yu, MD, PhD principal investigator
Kaohsiung Medical University
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 pegylated interferon alpha 2a and plus ribavirin, Pegylated interferon alfa-2a and ribavirin and pegylated interferon alpha 2a and ribavirin in people with Chronic Hepatitis C, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 8 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 Dec 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 Taiwan. 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 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?
Efficacy - Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4 Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period (time frame: 1.5 year). 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 NCT00540345, which also lists 5 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 30 Dec 2014.