## Protocol Section
### Identification Module
**NCT ID:** NCT02515279

**Brief Title:** An Observational Study of Peginterferon Alfa-2a Plus Ribavirin for Hepatitis C Virus (HCV) Infection in Austria

**Official Title:** A Non-Interventional Trial of Pegasys/Copegus in HCV Patients for 12 Months

#### Organization Study ID Info
**ID:** ML22273
#### Organization
**Class:** INDUSTRY
**Full Name:** Hoffmann-La Roche
### Status Module
#### Completion Date
**Date:** 2014-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-04-10

**Type:** ACTUAL

**Last Update Submit Date:** 2017-03-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2016-02-10

**Type:** ESTIMATED

**Results First Submit Date:** 2016-01-12

**Results First Submit QC Date:** 2016-01-12

#### Start Date
**Date:** 2008-11

**Status Verified Date:** 2017-03

#### Study First Post Date
**Date:** 2015-08-04
**Type:** ESTIMATED
**Study First Submit Date:** 2015-07-29
**Study First Submit QC Date:** 2015-07-31
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hoffmann-La Roche

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** This noninterventional, open-label study will observe the safety and tolerability of peginterferon alfa-2a in combination with ribavirin among Austrian participants treated for HCV infection according to routine practice.

### Conditions Module

**Conditions:**

- Hepatitis C

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 463

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.

**Intervention Names:**

- Drug: Peginterferon alfa-2a

- Drug: Ribavirin

**Label:** Participants With Hepatitis C

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Participants With Hepatitis C

**Description:** 180 micrograms subcutaneous weekly for 48 weeks.

**Name:** Peginterferon alfa-2a

**Other Names:**

- Pegasys

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Participants With Hepatitis C

**Description:** 1000-1600 mg day orally for 48 weeks.

**Name:** Ribavirin

**Other Names:**

- Copegus

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.

**Measure:** Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)

**Time Frame:** Up to 6 years

**Description:** Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). A participant was considered to have and end of treatment response if there was undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) after completing treatment. Participants with available PCR results were reported.

**Measure:** Percentage of Participants With End of Treatment Response

**Time Frame:** 12 months

**Description:** Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). SVR24 is defined as the percentage of participants with undetectable HCV RNA 24 weeks after completing treatment.

**Measure:** Percentage of Participants With Sustained Virologic Response 24 (SVR24)

**Time Frame:** 18 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Ongoing treatment with peginterferon alfa-2a and ribavirin at the discretion of the prescribing physician
* HCV infection

Exclusion Criteria:

* None specified

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** The study will enroll Austrian participants receiving peginterferon alfa-2a and ribavirin for HCV infection according to routine practice.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ried-innkreis

**Country:** Austria

**Facility:** A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.

**Zip:** 4910

#### Overall Officials

**Official 1:**

**Affiliation:** Hoffmann-La Roche

**Name:** Clinical Trials

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000004769

- Term: Enterovirus Infections

- ID: D000010850

- Term: Picornaviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000018178

- Term: Flaviviridae Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9592

- Name: Hepatitis A

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9611

- Name: Hepatitis C

- Relevance: HIGH

- As Found: Hepatitis C

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M7930

- Name: Enterovirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13745

- Name: Picornaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20324

- Name: Flaviviridae Infections

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006506

- Term: Hepatitis A

- ID: D000006526

- Term: Hepatitis C

- ID: D000006505

- Term: Hepatitis

### Intervention Browse Module - Ancestors

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M15083

- Name: Ribavirin

- Relevance: HIGH

- As Found: Bevacizumab

- ID: M247369

- Name: Peginterferon alfa-2a

- Relevance: HIGH

- As Found: Longitudinal

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000012254

- Term: Ribavirin

- ID: C000100416

- Term: Peginterferon alfa-2a

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** All participant who were enrolled in the study.

#### Event Groups

**Group ID:** EG000

**Title:** Participants With Hepatitis C

**Description:** All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.

**ID:** EG000

**Other Num Affected:** 148

**Other Num at Risk:** 463

**Serious Number Affected:** 18

**Serious Number At Risk:** 463

**Title:** Participants With Hepatitis C

**Frequency Threshold:** 5

#### Other Events

**Term:** Leukopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Thrombocytopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Depression

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Pruritus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 18.1

#### Serious Events

**Term:** Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 8

**Num At Risk:** 463

**Term:** Leukopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 463

**Term:** Thrombocytopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 463

**Term:** Influenza like illness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 463

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 463

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 463

**Term:** Diarrhoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 463

**Term:** Arthralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 463

**Term:** Depression

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 463

**Term:** Pneumonia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 463

**Term:** Drug eruption

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 463

**Term:** Pruritus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 463

**Term:** Syncope

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 463

**Time Frame:** up to 6 years

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 463

**Units:** Participants

### Group

**ID:** BG000

**Title:** Participants With Hepatitis C

**Description:** All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 13.3

**Value:** 41.0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 151

**Class Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 310

**Class Title:** Male

#### Measurement

**Group ID:** BG000

**Value:** 2

**Class Title:** Missing

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** NUMBER
**Title:** Sex/Gender, Customized
**Unit of Measure:** participants
**Population Description:** All participants who were enrolled in the study.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** The sustained viral response that had to be filled out 6 months (or later) after the end of treatment was documented poorly due to reasons such as participants that were lost to follow-up or the study closure was before the visit date for the SVR.
### Point of Contact
**Email:** genentech@druginfo.com
**Organization:** Hoffmann-LaRoche
**Phone:** 800-821-8590
**Title:** Medical Communications
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44.28
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.9
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 83.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9.7
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26.6
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.
**Parameter Type:** NUMBER
**Population Description:** All participants who were enrolled in the study.
**Reporting Status:** POSTED
**Time Frame:** Up to 6 years
**Title:** Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
**ID:** OG000
**Title:** Participants With Hepatitis C
#### Outcome Measure 2
**Description:** Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). A participant was considered to have and end of treatment response if there was undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) after completing treatment. Participants with available PCR results were reported.
**Parameter Type:** NUMBER
**Population Description:** All participants who were enrolled in the study. N (Number of participants analysed)=participants who were evaluable for this measure.
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Percentage of Participants With End of Treatment Response
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
**ID:** OG000
**Title:** Participants With Hepatitis C
#### Outcome Measure 3
**Description:** Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). SVR24 is defined as the percentage of participants with undetectable HCV RNA 24 weeks after completing treatment.
**Parameter Type:** NUMBER
**Population Description:** All participant who were enrolled in the study. N=number of participants evaluable for this measure.
**Reporting Status:** POSTED
**Time Frame:** 18 months
**Title:** Percentage of Participants With Sustained Virologic Response 24 (SVR24)
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
**ID:** OG000
**Title:** Participants With Hepatitis C
### Participant Flow Module
#### Group
**Description:** All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
**ID:** FG000
**Title:** Participants With Hepatitis C
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 31
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 9
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 18
##### Withdraw
**Type:** End-of-treatment visit not attended
###### Reason
**Group ID:** FG000
**Number of Subjects:** 17
##### Withdraw
**Type:** Other
###### Reason
**Group ID:** FG000
**Number of Subjects:** 22
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 463
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 359
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 104
**Has Results:** True