AzTrials
AzTrials

HIV InfectionPhase 4NCT00340080

Clinical Utility Of Genetic Screening For HLA-B*5701, On Susceptibility To Abacavir Hypersensitivity

A Phase 4 study testing Abacavir in people with HIV Infection, run by GlaxoSmithKline at 254 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Study to evaluate the utility of prospective HLA-B*5701 screening on the incidence of abacavir hypersensitivity (ABC HSR) in 1800 previously ABC-naive adults with HIV-1 from Europe, Australia and other countries as applicable. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infection
What is being tested?
Abacavir
How many people
1,806 participants
Where
254 sitesin 19 countries
Study dates
Apr 2006to not given
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

  • Infected with documented HIV-1.
  • Subjects are Abacavir-naive (subjects can be antiretroviral therapy (ART)-naive or experienced).
  • All subjects must have a clinical need for treatment with Abacavir (ABC) or an ABC-containing product that precedes the decision to participate in the study.
  • If subjects are therapy naive they must meet the criteria for commencing HAART according to local guidelines.
  • ABC and ABC-containing products are not recommended during pregnancy. A female is eligible to enter and participate in the study if she is of:
  • Non-child-bearing potential: women who are surgically sterile or post-menopausal, the latter indicated by history of no menses for a minimum of 1 year from the date of the screening visit.
Show all 11Show fewer
  • Child-bearing potential: women who provide a negative pregnancy test (beta-human chorionic gonadotrophin; beta-HCG) at Screening and who agree to one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the approved product label and the instructions of a physician, during the study period and through epicutaneous patch testing where appropriate):
  • Complete abstinence from intercourse from 4 weeks prior to administration of the ABC-containing compound, throughout the study, and for at least 4 weeks after discontinuation of ABC or ABC-containing product.
  • Double barrier method (e.g., male condom/spermicide, male condom/diaphragm, diaphragm/spermicide). Hormonal contraceptives will not be considered sufficient forms of contraception for this study.
  • Any intrauterine device with published data showing that the expected failure rate is <1% per year.
  • Sterilisation (male partner of female subject).

Who cannot join

  • Has previously received ABC-containing therapy.
  • Satisfies any contraindications or restrictions to ABC therapy as listed in the product labels. Treatment with ABC must be in line with the recommendations of the product label.
  • The subject or any of their healthcare providers is aware of the subjects HLA type.
  • Has undergone an allogeneic bone marrow transplant.
  • Has an active or acute CDC Clinical Category C event at screening. Treatment for the acute event must have been completed at least 30 days prior to Screening.
  • Current severe illness, including liver and renal failure, major organ allograft, malignancy requiring parenteral chemotherapy that can not be discontinued for the duration of the trial, or any other conditions which, in the opinion of the Investigator, would make the patient unsuitable for the study.
Show all 15Show fewer
  • Any laboratory abnormality at Screening which, in the opinion of the Investigator, should preclude the subject's participation in the study.
  • Pregnant women or women who are breastfeeding.
  • Any immunisation within 30 days prior to Day 1.
  • Subject is, in the opinion of the Investigator, unable to complete the 6 week Observation period and the EPT assessments as required.
  • Subject requires treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to Screening, or has an anticipated need for these agents within the study period.
  • Subject is enrolled in one or more investigational drug/vaccine protocols.
  • In France, an eligible subject is neither affiliated with nor a beneficiary of a social security category.
  • A subject will not be eligible for progression to Baseline (Day 1) if any of the following criteria apply:
  • A positive result for HLA-B*5701 in those subjects randomised to the genetic screening arm.

Trial locations and contacts

254 sites in 19 countries.

254 sites in 19 countries

France60 sites

  • GSK Investigational Site

    Aix-en-Provence, 13616

  • GSK Investigational Site

    Amiens, 80054

  • GSK Investigational Site

    Angers, 49000

  • GSK Investigational Site

    Annecy, 74011

  • GSK Investigational Site

    Avignon, 84000

  • GSK Investigational Site

    Besançon, 25030

  • GSK Investigational Site

    Bobigny, 93009

  • GSK Investigational Site

    Bondy, 93143

  • GSK Investigational Site

    Bordeaux, 33000

  • GSK Investigational Site

    Bordeaux, 33076

  • GSK Investigational Site

    Caen, 14000

  • GSK Investigational Site

    Cannes, 06401

  • GSK Investigational Site

    Clermont-Ferrand, 63058

  • GSK Investigational Site

    Corbeil-Essonnes, 91106

  • GSK Investigational Site

    Créteil, 94010

  • GSK Investigational Site

    Dijon, 21079

  • GSK Investigational Site

    Fréjus, 83608

  • GSK Investigational Site

    Grenoble, 38043

  • GSK Investigational Site

    La Roche-sur-Yon, 85025

  • GSK Investigational Site

    La Rochelle, 17019

  • GSK Investigational Site

    Le Kremlin-Bicêtre, 94275

  • GSK Investigational Site

    Levallois-Perret, 92300

  • GSK Investigational Site

    Lyon, 69437

  • GSK Investigational Site

    Marseille, 13005

  • GSK Investigational Site

    Marseille, 13006

  • GSK Investigational Site

    Marseille, 13274

  • GSK Investigational Site

    Marseille, 13285

  • GSK Investigational Site

    Marseille, 13915

  • GSK Investigational Site

    Metz, 57000

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Mulhouse, 68000

  • GSK Investigational Site

    Nantes, 44093

  • GSK Investigational Site

    Nice, 06202

  • GSK Investigational Site

    Nîmes, 30029

  • GSK Investigational Site

    Niort, 79021

  • GSK Investigational Site

    Orléans, 45100

  • GSK Investigational Site

    Paris, 75014

  • GSK Investigational Site

    Paris, 75018

  • GSK Investigational Site

    Paris, 75475

  • GSK Investigational Site

    Paris, 75651

  • GSK Investigational Site

    Paris, 75679

  • GSK Investigational Site

    Paris, 75970

  • GSK Investigational Site

    Perpignan, 66046

  • GSK Investigational Site

    Poitiers, 86021

  • GSK Investigational Site

    Quimper, 29107

  • GSK Investigational Site

    Reims, 51092

  • GSK Investigational Site

    Rennes, 35033

  • GSK Investigational Site

    Rouen, 76030

  • GSK Investigational Site

    Saint-Brieuc, 22023

  • GSK Investigational Site

    Saint-Denis, 93205

  • GSK Investigational Site

    Saint-Etienne, 42055

  • GSK Investigational Site

    Saint-Germain-en-Laye, 78100

  • GSK Investigational Site

    Strasbourg, 67000

  • GSK Investigational Site

    Toulouse, 31059

  • GSK Investigational Site

    Tourcoing, 59208

  • GSK Investigational Site

    Tours, 37044

  • GSK Investigational Site

    Troyes, 10003

  • GSK Investigational Site

    Valence, 26953

  • GSK Investigational Site

    Valenciennes, 59300

  • GSK Investigational Site

    Villejuif, 94804

Other trials in France

Spain36 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Alcalá de Henares, 28805

  • GSK Investigational Site

    Alicante, 03010

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Baracaldo/Vizcaya, 48903

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Barcelona, 08025

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08907

  • GSK Investigational Site

    Barcelona, 8400

  • GSK Investigational Site

    Bilbao, 48013

  • GSK Investigational Site

    Calella, 08370

  • GSK Investigational Site

    Córdoba, 14004

  • GSK Investigational Site

    Elche (Alicante), 03202

  • GSK Investigational Site

    Granada, 18003

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28029

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Madrid

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Marid, 28040

  • GSK Investigational Site

    Mataró, 08034

  • GSK Investigational Site

    Oviedo, 33006

  • GSK Investigational Site

    Reus, 43201

  • GSK Investigational Site

    San Sebastián, 20014

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Seville, 41013

  • GSK Investigational Site

    Seville, 41041

  • GSK Investigational Site

    Seville, 41071

  • GSK Investigational Site

    Tarragona, 43007

  • GSK Investigational Site

    Valencia, 46010

  • GSK Investigational Site

    Valencia, 46015

  • GSK Investigational Site

    Vigo ( Pontevedra), 36204

  • GSK Investigational Site

    Vitoria-Gasteiz, 01009

Other trials in Spain

Italy33 sites

  • GSK Investigational Site

    Asti, Piedmont, 14100

  • GSK Investigational Site

    Bari, Apulia, 70124

  • GSK Investigational Site

    Bergamo, Lombardy, 24128

  • GSK Investigational Site

    Bologna, Emilia-Romagna, 40133

  • GSK Investigational Site

    Bologna, Emilia-Romagna, 40138

  • GSK Investigational Site

    Bolzano, Trentino-Alto Adige, 39100

  • GSK Investigational Site

    Brescia, Lombardy, 25125

  • GSK Investigational Site

    Busto Arsizio (va), Lombardy, 21052

  • GSK Investigational Site

    Cagliari, Sardinia, 09121

  • GSK Investigational Site

    Catania, Sicily, 95100

  • GSK Investigational Site

    Catanzaro, Calabria, 88100

  • GSK Investigational Site

    Cuggiono (mi), Lombardy, 20012

  • GSK Investigational Site

    Ferrara, Emilia-Romagna, 44100

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Grosseto, Tuscany, 58100

  • GSK Investigational Site

    Latina, Lazio, 04100

  • GSK Investigational Site

    Milan, Lombardy, 20127

  • GSK Investigational Site

    Milan, Lombardy, 20142

  • GSK Investigational Site

    Milan, Lombardy, 20157

  • GSK Investigational Site

    Naples, Campania, 80131

  • GSK Investigational Site

    Padova, Veneto, 35128

  • GSK Investigational Site

    Pallanza (Verbania), Piedmont, 28921

  • GSK Investigational Site

    Piacenza, Emilia-Romagna, 29100

  • GSK Investigational Site

    Rimini, Emilia-Romagna, 47900

  • GSK Investigational Site

    Rome, Lazio, 00161

  • GSK Investigational Site

    Rome, Lazio, 00185

  • GSK Investigational Site

    Salerno, Campania, 84131

  • GSK Investigational Site

    Sanremo (im), Liguria, 18032

  • GSK Investigational Site

    Sassari, Sardinia, 71000

  • GSK Investigational Site

    Torrette Di Ancona (an), The Marches, 60020

  • GSK Investigational Site

    Treviso, Veneto, 31100

  • GSK Investigational Site

    Turin, Piedmont, 10149

  • GSK Investigational Site

    Vicenza, Veneto, 36100

Other trials in Italy

Germany26 sites

  • GSK Investigational Site

    Berlin, State of Berlin, 13353

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44791

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50937

  • GSK Investigational Site

    Dortmund, North Rhine-Westphalia, 44137

  • GSK Investigational Site

    Erlangen, Bavaria, 91054

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45122

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60590

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79098

  • GSK Investigational Site

    Fürth, Bavaria, 90762

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 20146

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • GSK Investigational Site

    Hamburg, 20095

  • GSK Investigational Site

    Hanover, Lower Saxony, 30159

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Kiel, Schleswig-Holstein, 24116

  • GSK Investigational Site

    Leipzig, Saxony, 04170

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39120

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55116

  • GSK Investigational Site

    Munich, Bavaria, 80331

  • GSK Investigational Site

    Munich, Bavaria, 80335

  • GSK Investigational Site

    Munich, Bavaria, 80801

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48143

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48149

  • GSK Investigational Site

    Osnabrück, Lower Saxony, 49090

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70197

  • GSK Investigational Site

    Würzburg, Bavaria, 97080

Other trials in Germany

United Kingdom23 sites

  • GSK Investigational Site

    Belfast, BT12 6BA

  • GSK Investigational Site

    Birmingham, WS2 9PS

  • GSK Investigational Site

    Coventry, CV1 4FH

  • GSK Investigational Site

    Derby, Derbyshire, DE1 2QY

  • GSK Investigational Site

    Dudley, Birmingham, DY1 4SE

  • GSK Investigational Site

    East Yorkshire, HU16 5JQ

  • GSK Investigational Site

    Farnworth, Bolton, BL4 0JR

  • GSK Investigational Site

    Glasgow, G12 0YN

  • GSK Investigational Site

    Gloucester, GL1 3NN

  • GSK Investigational Site

    Leicester, LE1 5WW

  • GSK Investigational Site

    London, N18 1QX

  • GSK Investigational Site

    London, NW3 2QG

  • GSK Investigational Site

    London, SE13 6LR

  • GSK Investigational Site

    London, SW10 9TH

  • GSK Investigational Site

    London, SW17 0QT

  • GSK Investigational Site

    London, W2 1NY

  • GSK Investigational Site

    Manchester, Lancashire, M8 5RB

  • GSK Investigational Site

    Middlesbrough, TS4 3BW

  • GSK Investigational Site

    Nottingham, Nottinghamshire, NG5 1PB

  • GSK Investigational Site

    Plaistow, London, E13 8SL

  • GSK Investigational Site

    Sheffield, S10 2JF

  • GSK Investigational Site

    Stoke-on-Trent, Staffordshire, ST4 7PA

  • GSK Investigational Site

    Woolwich, London, London, SE18 4QH

Other trials in United Kingdom

Russia16 sites

  • GSK Investigational Site

    Barnaul, 656010

  • GSK Investigational Site

    Belgorod, 308036

  • GSK Investigational Site

    Krasnodar, 350015

  • GSK Investigational Site

    Lipetsk, 398043

  • GSK Investigational Site

    Moscow, 105275

  • GSK Investigational Site

    Murmansk, 183001

  • GSK Investigational Site

    N.Novgorod, 603005

  • GSK Investigational Site

    Oryol, 302040

  • GSK Investigational Site

    Perm, 614990

  • GSK Investigational Site

    Ryazan, 390046

  • GSK Investigational Site

    Saint Petersburg, 196645

  • GSK Investigational Site

    Saint Petersburg

  • GSK Investigational Site

    Samara

  • GSK Investigational Site

    Saratov, 410009

  • GSK Investigational Site

    Smolensk, 214006

  • GSK Investigational Site

    Volgograd, 400040

Other trials in Russia

Netherlands13 sites

  • GSK Investigational Site

    Alkmaar, 1815 JD

  • GSK Investigational Site

    Amsterdam, 1091 AC

  • GSK Investigational Site

    Arnhem, 6815 AD

  • GSK Investigational Site

    Enschede, 7511JX

  • GSK Investigational Site

    Flushing, 4382 EE

  • GSK Investigational Site

    Groningen, 9713 GZ

  • GSK Investigational Site

    Nijmegen, 6525 GA

  • GSK Investigational Site

    Rotterdam, 3015 GD

  • GSK Investigational Site

    Rotterdam, 3078 HT

  • GSK Investigational Site

    The Hague, 2512 VA

  • GSK Investigational Site

    The Hague, 2545 CH

  • GSK Investigational Site

    Tilburg, 5022 GC

  • GSK Investigational Site

    Zwolle, 8025 AB

Other trials in Netherlands

Belgium8 sites

  • GSK Investigational Site

    Bruges, 8000

  • GSK Investigational Site

    Brussels, 1000

  • GSK Investigational Site

    Brussels, 1050

  • GSK Investigational Site

    Brussels, 1070

  • GSK Investigational Site

    Brussels, 1090

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Liège, 4000

Other trials in Belgium

Portugal8 sites

  • GSK Investigational Site

    Almada, 2805 - 267

  • GSK Investigational Site

    Amadora, 2720-276

  • GSK Investigational Site

    Aveiro, 4814-501

  • GSK Investigational Site

    Cascais, 2750

  • GSK Investigational Site

    Lisbon, 1150-242

  • GSK Investigational Site

    Monte Funchal, 9054-535

  • GSK Investigational Site

    Ponta Delgada, 9500-270

  • GSK Investigational Site

    Porto, 4369-004

Other trials in Portugal

Switzerland8 sites

  • GSK Investigational Site

    Basel, 4031

  • GSK Investigational Site

    Bruderholz, 4101

  • GSK Investigational Site

    La Chaux-de-Fonds, CH 2301

  • GSK Investigational Site

    Lausanne, 1004

  • GSK Investigational Site

    Lausanne, 1011

  • GSK Investigational Site

    Lugano, 6900

  • GSK Investigational Site

    Sankt Gallen, 9007

  • GSK Investigational Site

    Zurich, 8038

Other trials in Switzerland

Austria5 sites

  • GSK Investigational Site

    Graz, A-8020

  • GSK Investigational Site

    Innsbruck, A-6020

  • GSK Investigational Site

    Linz, A-4020

  • GSK Investigational Site

    Salzburg, A-5020

  • GSK Investigational Site

    Vienna, A-1090

Other trials in Austria

Israel4 sites

  • GSK Investigational Site

    Kfar Saba, 44281

  • GSK Investigational Site

    Ramat Gan, 52621

  • GSK Investigational Site

    Rehovot, 76100

  • GSK Investigational Site

    Tel Aviv, 64239

Other trials in Israel

Poland4 sites

  • GSK Investigational Site

    Bydgoszcz, 85-030

  • GSK Investigational Site

    Chorzów, 41-500

  • GSK Investigational Site

    Szczecin, 71-455

  • GSK Investigational Site

    Warsaw, 01-201

Other trials in Poland

Romania3 sites

  • GSK Investigational Site

    Bucharest, 021105

  • GSK Investigational Site

    Constanța, 900709

  • GSK Investigational Site

    Iași, 700116

Other trials in Romania

Australia2 sites

  • GSK Investigational Site

    Darlinghurst, New South Wales, 2010

  • GSK Investigational Site

    Miami, Queensland, 4220

Other trials in Australia

Norway2 sites

  • GSK Investigational Site

    Fredrikstad, 1606

  • GSK Investigational Site

    Oslo, 0450

Other trials in Norway

Ireland1 site

  • GSK Investigational Site

    Dublin, 8

Other trials in Ireland

Latvia1 site

  • GSK Investigational Site

    Riga, LV1006

Other trials in Latvia

Slovenia1 site

  • GSK Investigational Site

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*5701) for Susceptibility to Abacavir Hypersensitivity

Study to evaluate the utility of prospective HLA-B*5701 screening on the incidence of abacavir hypersensitivity (ABC HSR) in 1800 previously ABC-naive adults with HIV-1 from Europe, Australia and other countries as applicable. The study has two (co-primary) objectives: i) to determine if screening for HLA-B*5701 prior to ABC-containing HAART results in a lower incidence of clinically-suspected HSR versus current standard of care (no genetic screening) and ii) to determine if screening for HLA-B*5701 prior to ABC-containing HAART, results in a significantly lower incidence of immunologically-confirmed HSR versus current standard of care (no genetic screening or patch testing). The study consists of up to a 28-day screening period, a randomised observation period (Day 1 through Week 6) and, for subjects experiencing a suspected ABC HSR and a subset of ABC-tolerant subjects, an epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control) and a Genetic Screening Arm (prospective genetic screening). Subjects identified as HLA-B*5701 positive in the prospective Genetic Screening Arm will not receive ABC and will be excluded from further study. Subjects who experience suspected ABC HSR during the 6-week observation will be withdrawn from ABC-containing product and undergo EPT patch testing 6 weeks later.

Conditions
HIV Infection
Being tested
Abacavir
Keywords
Abacavir, Pharmacogenetics, hypersensitivity, HLA-B*5701
Medical subject headings
HIV Infections, Hypersensitivity

What participants receive

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

  • AbacavirDrug

What is being measured

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

  1. Incidence of clinically-suspected ABC HSR during the 6-week observation period. Incidence of immunologically-confirmed ABC HSR. The clinical diagnosis of which occurs over the 6-week observation period.

Secondary outcomes (1)

  1. Incidence of clinically-suspected ABC HSR in Caucasians and in different ethnic sub-groups. Sensitivity and specificity, positive and negative predictive value of genetic screening for HLA-B*5701 for susceptibility of HSR.

Timeline

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

  1. First posted21 Jun 2006 (estimated)
  2. Study startApr 2006

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,806 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00340080
Sponsor's protocol ID
CNA106030
Other IDs
PREDICT-1
Status last verified
Jan 2010
First submitted
19 Jun 2006
Last updated
25 Jan 2010
Results posted
No

Publications

  • Mallal S, Phillips E, Carosi G, Molina JM, Workman C, Tomazic J, Jagel-Guedes E, Rugina S, Kozyrev O, Cid JF, Hay P, Nolan D, Hughes S, Hughes A, Ryan S, Fitch N, Thorborn D, Benbow A; PREDICT-1 Study Team. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med. 2008 Feb 7;358(6):568-79. doi: 10.1056/NEJMoa0706135.

    PubMed 18256392

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Abacavir in people with HIV Infection, run by GlaxoSmithKline at 254 sites in 19 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 11 inclusion and 15 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 25 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 254 sites in France, Spain, Italy, Germany, United Kingdom and 14 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. 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?

Incidence of clinically-suspected ABC HSR during the 6-week observation period. Incidence of immunologically-confirmed ABC HSR. The clinical diagnosis of which occurs over the 6-week observation period.. 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 NCT00340080, 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 25 Jan 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in