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CoughPhase 3NCT00958776

A Study to Evaluate the Efficacy and Safety of IV Peramivir in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Influenza

A Phase 3 study testing Peramivir+SOC in people with Cough and Sore Throat, run by BioCryst Pharmaceuticals at 196 sites in 23 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

A Phase 3, multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of peramivir administered intravenously in addition to standard of care compared to standard of care alone in adults and adolescents who are hospitalized due to serious influenza. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Cough, Sore Throat, Nasal Congestion
What is being tested?
Peramivir+SOC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
405 participants
Where
196 sitesin 23 countries
Study dates
Nov 2009to Oct 2013
Phase
Phase 3
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥12 years of age, male or female.
  • Able to provide informed consent, or for whom consent may be provided by guardian, unless informed consent provided by a guardian or a legally authorized representative is not consistent with applicable local or ethical concerns, procedures, directives and/or guidelines.
  • Subject must have at least one of the following clinical presentations at Screening:
  • Oral temperature ≥ 38.0 °C (≥100.4 °F), ≥38.6°C (≥101.4 °F) tympanic or rectal OR
  • Oxygen saturation <92%, OR
  • Two out of the following three vital signs:
Show all 21Show fewer
  • Respiration rate >24/minute, Heart rate >100/minute, Systolic BP <90 mmHg
  • Presence of at least one respiratory symptom (cough, sore throat, or nasal congestion) of any severity (mild, moderate, or severe).
  • Presence of at least one constitutional symptom (headache, myalgia, feverishness, or fatigue) of any severity (mild, moderate, or severe).
  • Onset of illness no more than 72 hours before presentation. Note: Time of onset of illness is defined as the earlier of either (1) the time when the temperature was first measured as elevated, OR (2) the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
  • Either:
  • Severity of illness that, in the Investigator's judgment, justifies hospitalization of the subject for supportive care.
  • OR
  • Presence of one or more of the following factors:
  • Age ≥60 years. Presence of chronic obstructive pulmonary disease (COPD) or other chronic lung disease requiring daily pharmacotherapy.
  • Current history of congestive heart failure or angina. Presence of diabetes mellitus, clinically stable or unstable. Transcutaneous oxygen saturation <94% without supplemental oxygen for at least 5 minutes, or a medically significant decrease in oxygen saturation from an established baseline value (an investigative site at altitude >2000 ft above sea level will utilize different criteria for oxygen saturation).
  • History of chronic renal impairment not requiring peritoneal dialysis. Serum creatinine > 2.0 mg/dL or > 177 μmol/L.
  • Diagnosis of Influenza by satisfying one of the following:
  • Clinical Influenza with Positive Diagnostic Test. Subjects who have a positive rapid antigen test (RAT) for influenza A and/or influenza B (using a Sponsor-approved test kit), or positive test (using other methodology) for influenza A and/or B virus antigen or RNA performed in a clinical laboratory at the screening/enrollment evaluation are eligible for enrollment.
  • OR
  • Clinical Influenza with Negative Rapid Antigen Test (RAT). Subjects with a negative RAT test may be enrolled once the site has been approved by the Sponsor to enroll such subjects, based on documentation of an outbreak of influenza in the community. An influenza outbreak may be documented in the catchment area of the hospital via one of the following methods: 1) local confirmation of influenza A or B infection in the current influenza season by a) the institution's local laboratory, or b) the local public health system, or c) the national public health system, or d) a laboratory of a recognized multinational influenza surveillance scheme such as the European Influenza Surveillance Network (EISN); 2) prior enrollment of a RAT positive subject into this study at the same institution in the current influenza season.

Who cannot join

  • Subjects who have been hospitalized for greater than 24 hours (not including time spent in the Emergency Department).
  • Treatment with any dose(s) of rimantadine, amantadine, ribavirin, zanamivir, or oseltamivir in the previous 7 days.
  • Blood platelet count of < 20 x 109/L at the time of the screening evaluation.
  • Serum bilirubin > 6 mg/dL or > 105 μmol/L at time of screening evaluation.
  • Serum ALT or AST > 5 times the upper limit of normal at time of screening evaluation.
  • Congestive heart failure of NYHA Class III or Class IV functional status.
Show all 20Show fewer
  • Serum creatinine > 5.0 mg/dL or > 500 μmol/L at time of screening evaluation.
  • Subjects who require peritoneal dialysis.
  • Altered neurologic status as defined by a Glasgow Coma Score of ≤ 9, unless medically induced.
  • Females who are pregnant (positive urine or serum pregnancy test at screening evaluation) or breastfeeding.
  • Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy. Subjects who have completed treatment 30 days prior to enrollment are not excluded. Hormone treatment for cancer is also not excluded.
  • Prior hematopoietic stem cell transplantation or solid organ transplant during the previous 4 months.
  • HIV infection with a known CD4 count < 200 cells/mm3 unless on a stable highly active antiretroviral therapy (HAART) for at least 6 months.
  • Presence of a pre-existing chronic infection that is undergoing or requiring medical therapy (eg, tuberculosis). Subjects with chronic osteomyelitis or Hepatitis B or C not requiring treatment are not excluded.
  • Presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study.
  • Previous treatment with intravenous or intramuscular peramivir.
  • Participation as a subject in any study of an experimental treatment for any condition within the 30 days prior to the time of the screening evaluation.
  • Subjects diagnosed with Cystic Fibrosis.
  • Subjects with confirmed clinical evidence of acute non-influenzal infection at the time of screening evaluation.
  • Subjects who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.

Trial locations and contacts

196 sites in 23 countries.

196 sites in 23 countries

United States60 sites

  • Study site

    Allentown, Pennsylvania

  • Study site

    Annapolis, Maryland

  • Study site

    Baltimore, Maryland

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of North Carolina at Chapel Hill AIDS Clinical Trials Unit

    Chapel Hill, North Carolina, 27599

  • Study site

    Charleston, South Carolina

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Study site

    Columbus, Georgia

  • Remington-Davis, Inc.

    Columbus, Ohio, 43215

  • Study site

    Dayton, Ohio

  • DeKalb Medical Center

    Decatur, Georgia, 30033

  • Study site

    Denver, Colorado

  • Wayne State University - Hutzel Hospital

    Detroit, Michigan, 48201

  • Wayne State University, Department of Emergency Medicine

    Detroit, Michigan, 48201

  • Study site

    Detroit, Michigan

  • Study site

    East Providence, Rhode Island

  • Study site

    Fort Lauderdale, Florida

  • Kentucky Lung Clinic

    Hazard, Kentucky, 41701

  • Study site

    Honolulu, Hawaii

  • Study site

    Kettering, Ohio

  • Study site

    La Mesa, California

  • Study site

    Las Vegas, Nevada

  • Regional Infection Diseases Infusion Center Inc.

    Lima, Ohio, 45801

  • Study site

    Long Beach, California

  • Study site

    Manhasset, New York

  • Study site

    Miami, Florida

  • Study site

    Modesto, California

  • Medical Arts Associates, Ltd.

    Moline, Illinois, 61265

  • Study site

    Natchitoches, Louisiana

  • Study site

    New Brunswick, New Jersey

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Oceanside, California

  • Pulmonary Consultants PC Physicians Medical Group, Inc.

    Orange, California, 92868

  • Study site

    Orange, California

  • Study site

    Orlando, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Carilion Infectious Disease

    Roanoke, Virginia, 24014

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • UC Davis Medical Center

    Sacramento, California, 95817

  • VA Medical Center - Salem

    Salem, Virginia, 24153

  • Study site

    San Antonio, Texas

  • Sharp Chula Vista Medical Center

    San Diego, California, 91911

  • Study site

    San Diego, California

  • Study site

    Savannah, Georgia

  • Study site

    Sioux Falls, South Dakota

  • Study site

    South Bend, Indiana

  • Study site

    Springfield, Illinois

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Study site

    St Louis, Missouri

  • Study site

    The Bronx, New York

  • ID Clinical Research, LTD

    Toledo, Ohio, 43608

  • Medical College Of Ohio

    Toledo, Ohio, 43614

  • Study site

    Toledo, Ohio

  • William Beaumont Hospital

    Troy, Michigan, 48085

  • Washington Hospital Center CAR

    Washington D.C., District of Columbia, 20010

  • Study site

    Washington D.C., District of Columbia

  • Study site

    West Palm Beach, Florida

  • Drogue Medical, LLC

    Wheat Ridge, Colorado, 80033

  • Florida Hospital

    Winter Park, Florida, 32790-2706

Other trials in United States

India28 sites

  • Study site

    Ahmedabad, Gujarat

  • Study site

    Bangalore, Karnataka

  • Study site

    Bikaner, Rajasthan

  • Apollo First Med Hospitals

    Chennai, Tamil Nadu, 600010

  • Life Line Multispecialty Hospital

    Chennai, Tamil Nadu, 600096

  • Study site

    Chennai, Tamil Nadu

  • Study site

    Cherthala, Maharashtra

  • Study site

    Coimbatore, Tamil Nadu

  • Study site

    Delhi, National Capital Territory of Delhi

  • Study site

    Ernākulam, Kerala

  • Study site

    Faridabad, Haryana

  • Study site

    Hyderabad, Andhra Pradesh

  • Fortis Escort Hospital

    Jaipur, Rajasthan, 302017

  • Study site

    Karamsad, Gujarat

  • Study site

    Kolkata, West Bengal

  • Study site

    Lucknow, Uttar Pradesh

  • Study site

    Mangalore, Karnataka

  • Study site

    Mohali, Punjab

  • Study site

    Mumbai, Maharashtra

  • Study site

    Nagpur, Maharashtra

  • Study site

    Nashik, Maharashtra

  • Study site

    Pune, Maharashtra

  • Study site

    Secunderabad, Andhra Pradesh

  • Study site

    Srinagar, Jammu and Kashmir

  • Study site

    Surat, Gujarat

  • Study site

    Thrissur, Kerala

  • Study site

    Trivandrum, Kerala

  • Study site

    Vadodara, Gujarat

Other trials in India

South Africa10 sites

  • Study site

    Bloemfontein

  • Study site

    Dundee

  • Study site

    Durban

  • Study site

    Krugersdorp

  • Study site

    Limpopo

  • Study site

    Middelburg, Mpumalanga

  • Study site

    Port Elizabeth

  • Study site

    Pretoria

  • Study site

    Somerset West

  • Study site

    Worcester

Other trials in South Africa

Argentina9 sites

  • Hospital del Torax Dr. Antonio A. Cetrangolo

    Buenos Aires, 1638

  • Study site

    Buenos Aires

  • Study site

    Caba

  • Study site

    Córdoba

  • Study site

    Mendoza

  • Study site

    Merlo

  • Study site

    Rosario

  • Study site

    Santa Fe

  • Study site

    Vicente López

Other trials in Argentina

Brazil9 sites

  • Study site

    Belo Horizonte, Minas Gerais

  • Study site

    Campinas, São Paulo

  • Study site

    Curitiba, Paraná

  • Study site

    Passo Fundo, Rio Grande do Sul

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Study site

    Porto Alegre, Rio Grande do Sul

  • Study site

    Santo André, São Paulo

  • Study site

    Santos, São Paulo

  • Study site

    São Paulo, São Paulo

Other trials in Brazil

Bulgaria8 sites

  • Study site

    Plovdiv

  • DDPPDI - Ruse

    Rousse, 7002

  • Fifth MHAT-Sofia, AD

    Sofia, 1233

  • MHAT - Tokuda Hospital Sofia, AD

    Sofia, 1407

  • Military Medical Academy - MHAT

    Sofia, 1606

  • Study site

    Sofia

  • MHAT - Tokuda Hospital Sofia, AD

    Stara Zagora

  • MHAT 'Dr. St. Cherkezov', AD

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Ukraine8 sites

  • Study site

    Chernivtsi

  • Study site

    Donetsk

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Odesa

  • Study site

    Poltava

  • Study site

    Sumy

  • Study site

    Vinnytsia

Other trials in Ukraine

Canada7 sites

  • Study site

    Chicoutimi, Quebec

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • Study site

    Kelowna, British Columbia

  • Study site

    Kingston, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Sherbrooke, Quebec

  • Study site

    Toronto, Ontario

Other trials in Canada

Israel7 sites

  • Study site

    Afula

  • Study site

    Haifa

  • Study site

    Holon

  • Study site

    Jerusalem

  • Study site

    Kfar Saba

  • Study site

    Ramat Gan

  • Study site

    Tel Aviv

Other trials in Israel

Germany6 sites

  • Study site

    Berlin

  • Study site

    Cologne

  • Study site

    Erlangen

  • Study site

    Göttingen

  • Study site

    Mainz

  • Universitaetsklinikum Regensburg

    Regensburg, 93053

Other trials in Germany

Poland6 sites

  • Study site

    Bydgoszcz

  • Study site

    Łańcut

  • Study site

    Lodz

  • Study site

    Mielec

  • Study site

    Poznan

  • Study site

    Puławy

Other trials in Poland

Czechia5 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Study site

    Hradec Králové

  • Study site

    Prague

  • Study site

    Tábor

  • Krajska zdravotni, a.s. - Masarykova nemocnice v Ustinad La

    Ústí nad Labem, 401 13

Other trials in Czechia

Hungary5 sites

  • Study site

    Debrecen

  • Study site

    Fehérgyarmat

  • Fejer Megyei Szent Gyorgy Korhaz

    Székesfehérvár, 8000

  • Principal SMO Dr. Bugyi Istvan Korhaz Szentes

    Szentes, 6000

  • Study site

    Zalaegerszeg

Other trials in Hungary

Russia5 sites

  • Study site

    Engel's

  • Study site

    Niznhy Novgorod

  • Study site

    Novosibirsk

  • Study site

    Saint Petersburg

  • Study site

    Tomsk

Other trials in Russia

Chile4 sites

  • Hospital Clinico Regional Dr. Guillermo Grant Benavente

    Concepción

  • Hosp. de Urgencia Asistencia Publica Dr. Alejandro del Rio

    Santiago, 56 2 5681332

  • Study site

    Santiago

  • Study site

    Temuco

Other trials in Chile

Latvia4 sites

  • Study site

    Liepāja

  • Study site

    Rēzekne

  • Study site

    Valmiera

  • Study site

    Ventspils

Other trials in Latvia

Serbia4 sites

  • Study site

    Belgrade

  • Study site

    Kragujevac

  • Study site

    Niš

  • Study site

    Novi Sad

Other trials in Serbia

Belgium3 sites

  • Study site

    Brussels

  • Study site

    Liège

  • Study site

    Mons

Other trials in Belgium

Peru3 sites

  • Study site

    Arequipa

  • Study site

    Cuzco

  • Study site

    Lima

Other trials in Peru

Bosnia and Herzegovina2 sites

  • Study site

    Sarajevo

  • Study site

    Tuzla

Other trials in Bosnia and Herzegovina

Lebanon1 site

  • Study site

    Beirut

Other trials in Lebanon

Slovakia1 site

  • Study site

    Trnava

Other trials in Slovakia

United Kingdom1 site

  • Study site

    Leicester

Other trials in United Kingdom

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of Peramivir Administered Intravenously in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Serious Influenza

A Phase 3, multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of peramivir administered intravenously in addition to standard of care compared to standard of care alone in adults and adolescents who are hospitalized due to serious influenza.

Being tested
Peramivir+SOC, Placebo+SOC
Keywords
Influenza, Hospitalized, Antiviral, Flu
Medical subject headings
Cough, Pharyngitis, Nasal Obstruction, Headache, Fever, Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peramivir+SOCDrug

    • Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
    • Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

  • Placebo+SOCDrug

    Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Study groups in NCT00958776
Study groupRoleWhat they receive
Peramivir+SOCExperimental* Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. * Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Receives: Drug: Peramivir+SOC
Placebo+SOCPlacebo comparatorPlacebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Receives: Drug: Placebo+SOC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Clinical Resolution (Kaplan-Meier Estimate)

    Time to clinical resolution was defined as the time in hours from initiation of study treatment until normalization of at least 4 of the 5 signs within the respective normalization criteria, maintained for at least 24-hours. Time to clinical resolution was summarized by treatment group using the method of Kaplan-Meier. For subjects who did not experience clinical resolution, values were censored at the date of their last non-missing assessment of clinical resolution during the study (whether this assessment occurred as an inpatient or as an outpatient).

    Measured: 10 days

Secondary outcomes (6)

  1. Change (Reduction) in Influenza Virus Titer

    The reduction in viral shedding was assessed as the change from baseline in log10 tissue culture infective dose50 (TCID50/mL) and RT-PCR and was summarized for each treatment group and study visit.

    Measured: Baseline and 24, 48, 108 hours

  2. Time to Alleviation of Clinical Symptoms of Influenza

    Time to alleviation of clinical symptoms of influenza was measured as the time from the first dose of study drug through the time period in which all 7 symptoms of influenza (cough, sore throat, nasal congestion, myalgia [aches and pains], headache, feverishness, and fatigue) were absent or rated as no greater than mild for at least 24 hours. Time to alleviation of symptoms was estimated using the method of Kaplan-Meier. Subjects who did not have resolution of any individual clinical sign were censored at the time of their last non-missing assessment of that sign.

    Measured: 10 days

  3. Time to Resolution of Fever (Kaplan-Meier Estimate)

    Time to resolution of fever was measured as the time from initiation of study treatment until resolution of fever, maintained for at least 24 hours; temperature measurements taken less than 4 hours after antipyretic use were treated as missing values.

    Measured: 10 days

  4. Time to Resumption of Usual Activities

    Time to resumption of usual activities was determined from the visual analog scale (scale ranged from 0 to 10 where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully). Time to resumption of usual activities was summarized by treatment group using the method of Kaplan-Meier.

    Measured: 10 days

  5. Number of Subjects With ICU Admission

    The number of subjects requiring ICU admission post-randomization was summarized by treatment group.

    Measured: 10 days

  6. Duration of All ICU Admissions (Kaplan-Meier Estimate)

    Duration of postbaseline ICU admission was defined as the total number of days in the ICU for those subjects who had a post-baseline admission to the ICU. Only days starting after the initial postbaseline admission were included. If a subject's stay in the ICU was ongoing, the duration was censored at the last study visit. Subjects who did not have a postbaseline admission had a duration of 0.

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionNov 2012
  4. Study completionOct 2013

Why it stopped: This study was terminated for futility

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
405 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00958776
Sponsor's protocol ID
BCX1812-301
Status last verified
Jan 2015
First submitted
12 Aug 2009
Last updated
12 Feb 2015
Data monitoring committee
Yes

Publications

  • de Jong MD, Ison MG, Monto AS, Metev H, Clark C, O'Neil B, Elder J, McCullough A, Collis P, Sheridan WP. Evaluation of intravenous peramivir for treatment of influenza in hospitalized patients. Clin Infect Dis. 2014 Dec 15;59(12):e172-85. doi: 10.1093/cid/ciu632. Epub 2014 Aug 12.

    PubMed 25115871

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Peramivir+SOC in people with Cough and Sore Throat, run by BioCryst Pharmaceuticals at 196 sites in 23 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 21 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: stopped early, as of the sponsor's last update on 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 196 sites in United States, India, South Africa, Argentina, Brazil and 18 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 12 Feb 2015). 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?

Time to Clinical Resolution (Kaplan-Meier Estimate) (time frame: 10 days). 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 NCT00958776, which also lists 1 linked publication.

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 12 Feb 2015.

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