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CompletedNCT01604291Updated Mar 14, 2019Results posted

An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C

An observational study in Hepatitis C, Chronic, sponsored by Hoffmann-La Roche. Completed at 21 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-14.

Sponsored by Hoffmann-La Roche · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
991
Ages
18 Years and older
Sex
All
01

Study summary

This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.

02

Conditions studied

  • Hepatitis C, Chronic
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 991 is above the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Chronic hepatitis C patients initiating Pegasys-based treatment

Inclusion criteria

  • Adult patients, >/= 18 years of age
  • Chronic hepatitis C (all genotypes, naïve or treatment experienced, HCV mono-infected or HCV-HIV co-infected)
  • Receiving either dual therapy (Pegasys plus ribavirin) or triple therapy (Pegasys plus ribavirin plus telaprevir/boceprevir)
  • No contra-indications to Pegasys and ribavirin therapy or to treatment regimen containing protease inhibitor (telaprevir or boceprevir) as detailed in local Prescribing Information
  • Quantitative serum HCV RNA by PCR test before initiation of treatment

Exclusion criteria

Exclusion Criteria:

  • Hepatitis A/B co-infection
  • Evidence of severe illness, active malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • Pregnant or breast-feeding women
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
991 participants (actual)
Patient registry
No

Groups and cohorts

  • Cohort
06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Sustained Viral Response (SVR) at Week 24

    The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels \< 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion.

    Time frame: Week 24

Secondary outcomes

  1. Comparison of SVR at Week 24

    SVR at Week 24 is compared by treatment group, type of infection, prior treatments and genotype.

    Time frame: Week 24

  2. Number of Participants With SVR at Week 24 According to the Demographic Characteristics

    The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels \< 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion. Number of participants analysed signifies participants who were evaluated for outcome measure. Data for this outcome measure was not summarized for each arm. Hence, data is reported for all participants.

    Time frame: Week 24

  3. Percentage of Participants With Rapid Virologic Response (RVR) at Week 4

    RVR was defined as HCV-RNA \<50 IU/mL by Week 4

    Time frame: Week 4

  4. Percentage of Participants With Extended RVR

    Extended RVR was defined as HCV-RNA \<50 IU/mL at weeks 4 and 12 for participants treated with telaprevir; or at weeks 8 \& 24 for participants treated with boceprevir. The assessment was performed in participants who received triple therapy in treatment arms 'Peginterferon Alfa-2a + Ribavirin +Telaprevir' and 'Peginterferon Alfa-2a + Ribavirin + Boceprevir'.

    Time frame: Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group

  5. Percentage of Participants With Complete Early Virologic Response (cEVR)

    Complete early virologic response (cEVR) was defined as HCV-RNA \<50 IU/mL by Week 12

    Time frame: Week 12

  6. Percentage of Participants With End of Treatment Response (EoT)

    End-of-Treatment (EoT) response was defined as HCV-RNA \<50 IU/mL by the end of treatment.

    Time frame: Week 24

  7. Percentage of Participants With Virologic Relapse

    Virologic relapse was defined as detectable HCV-RNA during the treatment-free follow-up period in participants with HCV-RNA \<50 IU/mL at EoT.

    Time frame: Week 72

  8. Treatment Duration

    The average amount of time a treatment was prescribed to participants.

    Time frame: Week 48

  9. Time to First Dose Modification of Peginterferon Alfa-2a

    Time frame: Week 48

  10. Time to First Dose Modification of Ribavirin

    Time frame: Week 48

  11. Time to First Dose Modification of Telaprevir/Boceprevir

    Time frame: Week 48

  12. Percentage of Participants With Adverse Events (AEs)

    Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Safety analysis included 2 additional participants in arm 'Peginterferon Alfa-2a + Ribavirin + Telaprevir'. The safety parameters were analyzed by the treatment actually received by the participants.

    Time frame: Week 48

  13. Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia

    Time frame: Week 48

  14. Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia

    Time frame: Week 48

  15. Percentage of Participants Who Had SVR at Week 24 With Dose Modifications

    Participants with dose modifications who had achieved SVR at Week 24 were reported. Data was collected for all participants who had dose modification of Peginterferon alfa-2a, Ribavirin or Telaprevir/boceprevir in any of the treatment regimen during the study.

    Time frame: Week 24

07

Results

Posted Mar 14, 2019

Participant flow

The study was conducted at 21 investigational centers in Israel.

Participant flow — Overall Study
MilestonePeginterferon Alfa-2a + RibavirinPeginterferon Alfa-2a + Ribavirin + TelaprevirPeginterferon Alfa-2a + Ribavirin + BoceprevirNo Information on Treatment Allocation
Started31144319344
Completed31144319344
Not completed0000

Outcome measures

PrimaryPercentage of Participants With Sustained Viral Response (SVR) at Week 24

The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels \< 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion.

Time frame:
Week 24
Reported as:
Number · Percentage of Participants
Percentage of Participants With Sustained Viral Response (SVR) at Week 24
Percentage of ParticipantsPeginterferon Alfa-2a + RibavirinPeginterferon Alfa-2a + Ribavirin + TelaprevirPeginterferon Alfa-2a + Ribavirin + Boceprevir
Percentage of Participants With Sustained Viral Response (SVR) at Week 2487.2 (81.1 to 91.9)94.8 (91.6 to 97.1)85.2 (77.4 to 91.1)
SecondaryComparison of SVR at Week 24

SVR at Week 24 is compared by treatment group, type of infection, prior treatments and genotype.

Time frame:
Week 24
Reported as:
Number · Percentage of Participants
Comparison of SVR at Week 24
Percentage of ParticipantsPeginterferon Alfa-2a + RibavirinPeginterferon Alfa-2a + Ribavirin + TelaprevirPeginterferon Alfa-2a + Ribavirin + Boceprevir
HCV Mono Infection86.6 (80.3 to 91.5)94.8 (91.5 to 97.0)84.5 (77.2 to 91.1)
HIV/HCV Co-Infection100 (NA to NA)100 (NA to NA)—
Genotype 183.8 (68.0 to 93.8)94.9 (91.6 to 97.1)84.4 (77.2 to 91.1)
Other Genotypes88.2 (81.3 to 93.2)100 (NA to NA)—
Treatment - Naive89.7 (83.6 to 94.1)95.5 (89.5 to 98.5)86.7 (73.2 to 94.9)
Treatment - Experienced66.7 (41.0 to 86.7)94.5 (90.1 to 97.3)83.1 (73.6 to 91.9)
SecondaryNumber of Participants With SVR at Week 24 According to the Demographic Characteristics

The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels \< 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion. Number of participants analysed signifies participants who were evaluated for outcome measure. Data for this outcome measure was not summarized for each arm. Hence, data is reported for all participants.

Time frame:
Week 24
Reported as:
Count of participants · Participants
Number of Participants With SVR at Week 24 According to the Demographic Characteristics
ParticipantsAll Participants
Gender: Male - Achieved SVR 24316
Gender: Male - Did not achieve SVR33
Gender: Female - Achieved SVR 24198
Gender: Female - Did not achieve SVR20
Age - Achieved SVR 24513
Age - Did not achieve SVR44
Height - Achieved SVR 2444
Height - Did not achieve SVR44
Weight - Achieved SVR 2444
Weight - Did not achieve SVR44
Body Mass Index - Achieved SVR 2444
Body Mass Index - Did not achieve SVR44
Statistical analysis
  • All Participants · Chi-squared · p = 0.9109 (The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.)
  • All Participants · t-test, 1 sided · p = 0.1163 (A t-test was done to compare SVR participants to non-SVR.)
  • All Participants · t-test, 1 sided · p = 0.9269 (A t-test was done to compare SVR participants to non-SVR.)
  • All Participants · t-test, 1 sided · p = 0.3376 (A t-test was done to compare SVR participants to non-SVR.)
  • All Participants · t-test, 1 sided · p = 0.4618 (A t-test was done to compare SVR participants to non-SVR.)
SecondaryPercentage of Participants With Rapid Virologic Response (RVR) at Week 4

RVR was defined as HCV-RNA \<50 IU/mL by Week 4

Time frame:
Week 4
Reported as:
Number · Percentage of Participants
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
Percentage of ParticipantsPeginterferon Alfa-2a + RibvavirinPeginterferon Alfa-2a + Ribavirin +TelaprevirPeginterferon Alfa-2a + Ribavirin + Boceprevir
Percentage of Participants With Rapid Virologic Response (RVR) at Week 461.2 (54.4 to 67.6)70.9 (66.1 to 75.3)21.1 (15.0 to 28.4)
SecondaryPercentage of Participants With Extended RVR

Extended RVR was defined as HCV-RNA \<50 IU/mL at weeks 4 and 12 for participants treated with telaprevir; or at weeks 8 \& 24 for participants treated with boceprevir. The assessment was performed in participants who received triple therapy in treatment arms 'Peginterferon Alfa-2a + Ribavirin +Telaprevir' and 'Peginterferon Alfa-2a + Ribavirin + Boceprevir'.

Time frame:
Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group
Reported as:
Number · Percentage of Participants
Percentage of Participants With Extended RVR
Percentage of ParticipantsPeginterferon Alfa-2a + Ribavirin +TelaprevirPeginterferon Alfa-2a + Ribavirin + Boceprevir
Percentage of Participants With Extended RVR72.7 (67.7 to 77.2)70.7 (60.7 to 79.4)
SecondaryPercentage of Participants With Complete Early Virologic Response (cEVR)

Complete early virologic response (cEVR) was defined as HCV-RNA \<50 IU/mL by Week 12

Time frame:
Week 12
Reported as:
Number · Percentage of Participants
Percentage of Participants With Complete Early Virologic Response (cEVR)
Percentage of ParticipantsPeginterferon Alfa-2a + RibvavirinPeginterferon Alfa-2a + Ribavirin +TelaprevirPeginterferon Alfa-2a + Ribavirin + Boceprevir
Percentage of Participants With Complete Early Virologic Response (cEVR)75.0 (68.3 to 81.0)84.9 (80.9 to 88.4)62.0 (54.0 to 69.6)
SecondaryPercentage of Participants With End of Treatment Response (EoT)

End-of-Treatment (EoT) response was defined as HCV-RNA \<50 IU/mL by the end of treatment.

Time frame:
Week 24
Reported as:
Number · Percentage of Participants
Percentage of Participants With End of Treatment Response (EoT)
Percentage of ParticipantsPeginterferon Alfa-2a + RibvavirinPeginterferon Alfa-2a + Ribavirin +TelaprevirPeginterferon Alfa-2a + Ribavirin + Boceprevir
Percentage of Participants With End of Treatment Response (EoT)86.4 (81.8 to 90.1)81.9 (77.9 to 85.4)76.6 (69.9 to 82.4)
SecondaryPercentage of Participants With Virologic Relapse

Virologic relapse was defined as detectable HCV-RNA during the treatment-free follow-up period in participants with HCV-RNA \<50 IU/mL at EoT.

Time frame:
Week 72
Reported as:
Number · Percentage of Participants
Percentage of Participants With Virologic Relapse
Percentage of ParticipantsPeginterferon Alfa-2a + RibvavirinPeginterferon Alfa-2a + Ribavirin +TelaprevirPeginterferon Alfa-2a + Ribavirin + Boceprevir
Percentage of Participants With Virologic Relapse0.3 (0 to 1.9)0 (NA to NA)0 (NA to NA)
SecondaryTreatment Duration

The average amount of time a treatment was prescribed to participants.

Time frame:
Week 48
Reported as:
Mean · Weeks
Treatment Duration
WeeksPeginterferon Alfa-2a + RibavirinPeginterferon Alfa-2a + Ribavirin + TelaprevirPeginterferon Alfa-2a + Ribavirin + Boceprevir
Peginterferon Alfa-2a Treatment Duration26.2 ± 11.534.8 ± 15.236.1 ± 14.7
Ribavirin Treatment Duration26.2 ± 11.634.8 ± 15.236.1 ± 14.7
Telaprevir/ Boceprevir Treatment DurationNA ± NA11.8 ± 4.630.6 ± 14.9
SecondaryTime to First Dose Modification of Peginterferon Alfa-2a
Time frame:
Week 48
Reported as:
Mean · Days
Time to First Dose Modification of Peginterferon Alfa-2a
DaysPeginterferon Alfa-2a + RibavirinPeginterferon Alfa-2a + Ribavirin +TelaprevirPeginterferon Alfa-2a + Ribavirin + Boceprevir
Time to First Dose Modification of Peginterferon Alfa-2a418.5 ± 9.7247.6 ± 4.1328.4 ± 13.7
SecondaryTime to First Dose Modification of Ribavirin
Time frame:
Week 48
Reported as:
Mean · Days
Time to First Dose Modification of Ribavirin
DaysPeginterferon Alfa-2a + RibvavirinPeginterferon Alfa-2a + Ribavirin +TelaprevirPeginterferon Alfa-2a + Ribavirin + Boceprevir
Time to First Dose Modification of RibavirinNA ± NA61.4 ± 3.689.4 ± 6.8
SecondaryTime to First Dose Modification of Telaprevir/Boceprevir
Time frame:
Week 48
Reported as:
Mean · Days
Time to First Dose Modification of Telaprevir/Boceprevir
DaysPeginterferon Alfa-2a + Ribavirin +TelaprevirPeginterferon Alfa-2a + Ribavirin + Boceprevir
Time to First Dose Modification of Telaprevir/Boceprevir124.6 ± 0.782.3 ± 0.8
SecondaryPercentage of Participants With Adverse Events (AEs)

Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Safety analysis included 2 additional participants in arm 'Peginterferon Alfa-2a + Ribavirin + Telaprevir'. The safety parameters were analyzed by the treatment actually received by the participants.

Time frame:
Week 48
Reported as:
Number · Percentage of Participants
Percentage of Participants With Adverse Events (AEs)
Percentage of ParticipantsPeginterferon Alfa-2a + RibavirinPeginterferon Alfa-2a + Ribavirin + TelaprevirPeginterferon Alfa-2a + Ribavirin + Boceprevir
Percentage of Participants With Adverse Events (AEs)68.879.385.9
SecondaryMean Value of Hemoglobin in Participants With Treatment-Induced Anemia
Time frame:
Week 48
Reported as:
Mean · Grams per Deciliter (g/dl)
Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia
Grams per Deciliter (g/dl)Peginterferon Alfa-2a + RibavirinPeginterferon Alfa-2a + Ribavirin + TelaprevirPeginterferon Alfa-2a +Ribavirin + Boceprevir
Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia9.3 ± 1.69.2 ± 1.39.5 ± 1.3
SecondaryPercentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia
Time frame:
Week 48
Reported as:
Number · Percentage of Participants
Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia
Percentage of ParticipantsPeginterferon Alfa-2a + RibvavirinPeginterferon Alfa-2a + Ribavirin +TelaprevirPeginterferon Alfa-2a + Ribavirin + Boceprevir
RVB Dose Reduction3756.553.6
RBV Temporary Interrupted2.54.52.3
RBV Permanently Interrupted01.40.9
Use of Erythropotin18.527.329.1
Blood Transfusion17.318.812.7
DAA Permanently Discontinued01.40.5
Peg-IFN a-2a Dose Reduction2.51.15.5
No Other Action Done32.122.225.5
Other6.24.82.7
SecondaryPercentage of Participants Who Had SVR at Week 24 With Dose Modifications

Participants with dose modifications who had achieved SVR at Week 24 were reported. Data was collected for all participants who had dose modification of Peginterferon alfa-2a, Ribavirin or Telaprevir/boceprevir in any of the treatment regimen during the study.

Time frame:
Week 24
Reported as:
Number · percentage of participants
Percentage of Participants Who Had SVR at Week 24 With Dose Modifications
percentage of participantsAll Participants
Peginterferon alfa-2a15.70
Ribavirin55.56
Telaprevir/boceprevir0.78
Statistical analysis
  • All Participants · Chi-squared · p = 0.0463 · Phi-coefficient: -0.0835phi-coefficient is a measure of the degree of association between two binary variables
  • All Participants · Chi-squared · p = 0.2052 · Phi-coefficient: 0.0666phi-coefficient is a measure of the degree of association between two binary variables.
  • All Participants · Fisher Exact · p = 0.0033 · Phi-coefficient: -0.1672phi-coefficient is a measure of the degree of association between two binary variables.

Adverse events

Collected over Week 48. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Peginterferon Alfa-2a + Ribavirin—24/311 (7.7%)208/311 (66.9%)
Peginterferon Alfa-2a + Ribavirin +Telaprevir—78/445 (17.5%)338/445 (76%)
Peginterferon Alfa-2a + Ribavirin + Boceprevir—26/192 (13.5%)161/192 (83.9%)
Most frequent serious events
Showing 10 of 91
Most frequent serious events
EventPeginterferon Alfa-2a + RibavirinPeginterferon Alfa-2a + Ribavirin +TelaprevirPeginterferon Alfa-2a + Ribavirin + Boceprevir
AnaemiaBlood and lymphatic system disorders2/31130/4455/192
PyrexiaGeneral disorders5/31112/4454/192
RashSkin and subcutaneous tissue disorders0/3118/4450/192
PancytopeniaBlood and lymphatic system disorders0/3113/4453/192
Chest PainGeneral disorders2/3111/4453/192
PneumoniaInfections and infestations2/3111/4453/192
DeathGeneral disorders4/3111/4450/192
AstheniaGeneral disorders0/3115/4450/192
NeutropeniaBlood and lymphatic system disorders0/3110/4452/192
CellulitisInfections and infestations1/3110/4452/192
Most frequent other events
Showing 10 of 33
Most frequent other events
EventPeginterferon Alfa-2a + RibavirinPeginterferon Alfa-2a + Ribavirin +TelaprevirPeginterferon Alfa-2a + Ribavirin + Boceprevir
AnemiaBlood and lymphatic system disorders44/311162/44596/192
AstheniaGeneral disorders116/311169/44585/192
PruritusSkin and subcutaneous tissue disorders41/311133/44544/192
RashSkin and subcutaneous tissue disorders43/311124/44533/192
PyrexiaGeneral disorders47/31160/44544/192
DysgeusiaNervous system disorders23/31132/44542/192
NeutropeniaBlood and lymphatic system disorders27/31133/44540/192
NauseaGastrointestinal disorders40/31159/44534/192
HeadacheNervous system disorders55/31149/44526/192
Decreased AppetiteMetabolism and nutrition disorders51/31166/44527/192

Baseline characteristics

All Enrolled Participants

Age, Continuous
Age, Continuous(Years)Peginterferon Alfa-2a + RibavirinPeginterferon Alfa-2a + Ribavirin + TelaprevirPeginterferon Alfa-2a + Ribavirin + BoceprevirNo Information on Treatment AllocationTotal
Mean44.1 ± 10.650.3 ± 11.051.1 ± 11.648.1 ± 12.048.4 ± 11.4
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Peginterferon Alfa-2a + RibavirinPeginterferon Alfa-2a + Ribavirin + TelaprevirPeginterferon Alfa-2a + Ribavirin + BoceprevirNo Information on Treatment AllocationTotal
Female101161749345
Male21028211818628
Unknown0011718
08

Study locations

21 sites
  • Haemek Hospital; Gastroenterology
    Afula, 18101, Israel
  • Barzilai MC; Gastroenterology
    Ashkelon, 78278, Israel
  • Soroka Medical Center; Gastroenterology
    Beer Sheva, 84105, Israel
  • Hillel Yaffe Hospital; Gastroenterology
    Hadera, 38100, Israel
  • Rambam Medical Center; Gastroenterology - Liver Unit
    Haifa, 31096, Israel
  • Bnei-Zion Medical Center; Gastroenterology
    Haifa, 33394, Israel
  • Carmel Hospital; Liver Unit
    Haifa, 34362, Israel
  • Wolfson Hospital; Gastroenterology Unit
    Holon, 58100, Israel
  • Shaare Zedek Hospital Liver Unit; Liver Unit
    Jerusalem, 91031, Israel
  • Hadassah Hospital; Liver Unit
    Jerusalem, 91120, Israel
  • Meir Medical Center; Liver Unit
    Kfar Saba, 44281, Israel
  • Western Galilee Hospital - Nahariya
    Nahariya, 22100, Israel
  • Holy Family Medical Center; Liver Unit
    Nazareth, Israel
  • Hasharon Mc; Gastroenterology
    Petach Tikva, Israel
  • Beilinson-Rabin Liver Unit; Liver Unit
    Petah Tiqwa, Israel
  • Sheba Medical Center; Tel Hashomer
    Ramat Gan, 5262100, Israel
  • Kaplan Medical Center; Gastroenterology Unit
    Rehovot, 76100, Israel
  • Rebecca Sieff Medical Center; Liver Unit
    Safed, 13110, Israel
  • Tel-Aviv Sourasky Medical Center; Liver Unit
    Tel Aviv, 6423906, Israel
  • Poria Hospital; Gastroenterology
    Tiberias, Israel
  • Assaf Harofeh; Gastroenterology
    Zerifin, 6093000, Israel
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01604291
Lead sponsor
Hoffmann-La Roche
Collaborators
Clalit Health Services
Responsible party
Sponsor
First posted
May 23, 2012
Start date
May 28, 2012
Primary completion
Feb 10, 2016
Completion
Feb 10, 2016
Results posted
Mar 14, 2019
Last update
Mar 14, 2019

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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